ZOLL Medical Corporation
Pawtucket, RI, US
ZOLL MEDICAL CORPORATION appears in FDA device records in Pawtucket, RI. FDA records list 149 510(k) clearances between and , 119 PMA records and 4 registered establishments. As of , FDA records show 88 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to ZOLL Medical Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bio-Detek, Inc.510(k), enforcement report, recall
- Cardiac Science, Inc.510(k), enforcement report, recall
- Impact Instrumentation, Inc.510(k), enforcement report, recall
- Zoll Medical Corporation, World Wide Headquarters510(k), recall
510(k) clearance history
Showing 50 of 149FDA records hold 149 510(k) clearances for ZOLL Medical Corporation between 1981 and 2024. The busiest year on record is 2011, with 12. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 5 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 2 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 6 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 6 |
| 2004 | 9 |
| 2005 | 6 |
| 2006 | 5 |
| 2007 | 5 |
| 2008 | 8 |
| 2009 | 7 |
| 2010 | 6 |
| 2011 | 12 |
| 2012 | 9 |
| 2013 | 1 |
| 2014 | 9 |
| 2015 | 4 |
| 2017 | 2 |
| 2018 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233486 | 731 Series Ventilator | CBK | Substantially Equivalent | |
| K202375 | ZOLL Propaq M | MWI | Substantially Equivalent | |
| K180482 | ZOLL Propaq M | MHX | Substantially Equivalent | |
| K172653 | Power Infuser | FRN | Substantially Equivalent | |
| K162832 | 731 Series Ventilators | CBK | Substantially Equivalent | |
| K170533 | Model 330 Multifunction Aspirator | BTA | Substantially Equivalent | |
| K143714 | Powerheart G5 AED | MKJ | Substantially Equivalent | |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | MKJ | Substantially Equivalent | |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | MKJ | Substantially Equivalent | |
| K133239 | ZOLL E SERIES | MKJ | Substantially Equivalent | |
| K142915 | ZOLL X Series | MKJ | Substantially Equivalent | |
| K141774 | ZOLL X SERIES | MKJ | Substantially Equivalent | |
| K140502 | ZOLL E SERIES ALS | LDD | Substantially Equivalent | |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | MKJ | Substantially Equivalent | |
| K133484 | ZOLL X SERIES | MKJ | Substantially Equivalent | |
| K133269 | ZOLL X SERIES | MKJ | Substantially Equivalent | |
| K132488 | ZOLL CODE WRITER | DXJ | Substantially Equivalent | |
| K133196 | IMPACT MODEL 323 ASPIRATOR | JCX | Substantially Equivalent | |
| K122758 | POWERHEART G5 AED | MKJ | Substantially Equivalent | |
| K131919 | ZOLL EPCR IOS | DXJ | Substantially Equivalent | |
| K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER | MKJ | Substantially Equivalent | |
| K121865 | ZOLL RESCUENET 12-LEAD | MSX | Substantially Equivalent | |
| K120406 | ZOLL FULLY AUTOMATIC AED PLUS | MKJ | Substantially Equivalent | |
| K120907 | ZOLL R SERIES | MKJ | Substantially Equivalent | |
| K121367 | ZOLL PROPAQ XM | MHX | Substantially Equivalent | |
| K112660 | POCKETCPR | LIX | Substantially Equivalent | |
| K112761 | ZOLL PROPAQ MD | MKJ | Substantially Equivalent | |
| K112432 | ZOLL X SERIES | MKJ | Substantially Equivalent | |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | CBK | Substantially Equivalent | |
| K113176 | MYSENSE HEART | DSH | Substantially Equivalent | |
| K111296 | ZOLL RESCUENETLINK | MSX | Substantially Equivalent | |
| K111594 | ZOLL E SERIES | MKJ | Substantially Equivalent | |
| K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS | MKJ | Substantially Equivalent | |
| K110978 | ONESTEP PEDIATRIC MFE'S | MKJ | Substantially Equivalent | |
| K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR | DXJ | Substantially Equivalent | |
| K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE | MKJ | Substantially Equivalent | |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | CBK | Substantially Equivalent | |
| K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | MKJ | Substantially Equivalent | |
| K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | MKJ | Substantially Equivalent | |
| K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | MKJ | Substantially Equivalent | |
| K110154 | ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | MKJ | Substantially Equivalent | |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 | MKJ | Substantially Equivalent | |
| K102468 | ZOLL PROPAQ MD | LDD | Substantially Equivalent | |
| K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE | MKJ | Substantially Equivalent | |
| K102174 | ZOLL PROPAQ M | DRT | Substantially Equivalent | |
| K100654 | ZOLL PROPAQ MD | LDD | Substantially Equivalent | |
| K093211 | CARECENTER MD | DPS | Substantially Equivalent | |
| K091265 | ZOLL E SERIES WITH CPRREADYCHARGE | MKJ | Substantially Equivalent | |
| K092598 | ZOLL E SERIES WITH SPCO/SPMET OPTION | MKJ | Substantially Equivalent | |
| K090989 | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES | MKJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220908 | 1220908 | ZOLL MEDICAL CORPORATION | 269 MILL ROAD, CHELMSFORD, MA 01824 US | 2026 | and 19 more, listed in full below |
| 3038259592 | 3038259592 | ZOLL MEDICAL CORPORATION | 38 Upton Dr, Wilmington, MA 01887 US | 2026 | and 2 more, listed in full below |
| 1218058 | 1218058 | ZOLL Medical Corporation | 525 Narragansett Park Dr, Pawtucket, RI 02861 US | 2026 | |
| 2112020 | 2112020 | ZOLL Medical Corporation | 500 Burdick Pkwy, DEERFIELD, WI 53531 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MODAccessory To Continuous Ventilator (Respirator)
- LIXAid, Cardiopulmonary Resuscitation
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- HAMApparatus, Electrosurgical
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- MKJAutomated External Defibrillators (Non-Wearable)
- DXQBlood Pressure Cuff
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- JOLCatheter And Tip, Suction
- PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
- BTICompressor, Air, Portable
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GXZElectrode, Needle
- OVRKit, First Aid, Talking
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- DTEPulse-Generator, Pacemaker, External
- FRNPump, Infusion
- BTAPump, Portable, Aspiration (Manual Or Powered)
- DSHRecorder, Magnetic Tape, Medical
- JOWSleeve, Limb, Compressible
- BWFSpirometer, Therapeutic (Incentive)
- FOXStand, Infusion
- BTKStrap, Head, Gas Mask
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- BXPTransducer, Gas Flow
- CBKVentilator, Continuous, Facility Use
- BTLVentilator, Emergency, Powered (Resuscitator)
- LSZVentilator, High Frequency
- BZDVentilator, Non-Continuous (Respirator)
- MVKWearable Automated External Defibrillator
Recall records
Showing 25 of 88| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1323-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1322-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1321-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1320-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1319-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1318-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1317-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-1316-2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | Class II | Open, Classified | |
| Z-2324-2024 | ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C | G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest | Class II | Open, Classified | |
| Z-2130-2024 | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16 | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy | Class I | Open, Classified | |
| Z-1931-2019 | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients. | There is a potential for the device to fail to deliver energy to the patient. | Class II | Open, Classified | |
| Z-1938-2019 | Powerheart G5 Automatic AED | Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications. | Class II | Terminated | |
| Z-1945-2019 | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. | Class II | Terminated | |
| Z-0977-2018 | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians. | A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk. | Class II | Terminated | |
| Z-0812-2018 | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy to-use, durable, | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. | Class II | Terminated | |
| Z-0829-2016 | 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin. | Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. This is normal behavior when the impedance limit is exceeded. The high impedance electrodes require replacement. | Class II | Terminated | |
| Z-0055-2015 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Product sterility is not assured | Class II | Terminated | |
| Z-0054-2015 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Product sterility is not assured | Class II | Terminated | |
| Z-0053-2015 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Product sterility is not assured | Class II | Terminated | |
| Z-0052-2015 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Product sterility is not assured | Class II | Terminated | |
| Z-2660-2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. | Sterility of device is not assured | Class II | Terminated | |
| Z-2659-2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture. | Sterility of device is not assured | Class II | Terminated | |
| Z-2658-2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture. | Sterility of device is not assured | Class II | Terminated | |
| Z-1311-2014 | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used | Class II | Terminated | |
| Z-2565-2014 | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033 | Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators | Class II | Terminated |
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