GE Medical Systems Information Technologies, Inc.
El Paso, TX, US
GE Medical Systems Information Technologies, Inc. appears in FDA device records in El Paso, TX. FDA records list 171 510(k) clearances between and , 4 PMA records and 3 registered establishments. As of , FDA records show 43 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to GE Medical Systems Information Technologies, Inc. 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.
- General Electric Medical Systems Information Technologyrecall
510(k) clearance history
Showing 50 of 171FDA records hold 171 510(k) clearances for GE Medical Systems Information Technologies, Inc. between 1978 and 2026. The busiest year on record is 2003, with 17. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 3 |
| 1980 | 1 |
| 1982 | 4 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 4 |
| 1986 | 5 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 8 |
| 1991 | 11 |
| 1992 | 2 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 7 |
| 2003 | 17 |
| 2004 | 6 |
| 2005 | 9 |
| 2006 | 4 |
| 2007 | 5 |
| 2008 | 5 |
| 2009 | 6 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 6 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | Substantially Equivalent | |
| K251670 | MAC 7 Resting ECG Analysis System | DPS | Substantially Equivalent | |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | Substantially Equivalent | |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | DQK | Substantially Equivalent | |
| K233810 | Portrait VSM | MWI | Substantially Equivalent | |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O | MWI | Substantially Equivalent | |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | Substantially Equivalent | |
| K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ | MWI | Substantially Equivalent | |
| K230145 | ONE-CUF | DXQ | Substantially Equivalent | |
| K222586 | Mural Clinical Viewer | MHX | Substantially Equivalent | |
| K221904 | EK12 V2 Algorithm | MHX | Substantially Equivalent | |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | DPS | Substantially Equivalent | |
| K220732 | Mural Perinatal Surveillance | HGM | Substantially Equivalent | |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 | MHX | Substantially Equivalent | |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | MHX | Substantially Equivalent | |
| K203786 | MAC 7 - Resting ECG Analysis System | DPS | Substantially Equivalent | |
| K202189 | Graffiti | DQK | Substantially Equivalent | |
| K201941 | Monitor B125, Monitor B105 | MHX | Substantially Equivalent | |
| K173830 | MAC VU360 Resting ECG Analysis System | DPS | Substantially Equivalent | |
| K170155 | EK12 Algorithm | MHX | Substantially Equivalent | |
| K152993 | MUSE Cardiology Information System | DQK | Substantially Equivalent | |
| K141963 | 12SL ECG ANALYSIS PROGRAM | MHX | Substantially Equivalent | |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | DXJ | Substantially Equivalent | |
| K132437 | MARS HOLTER ANALYSIS WORKSTATION | DQK | Substantially Equivalent | |
| K130626 | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS | DQK | Substantially Equivalent | |
| K123996 | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | |
| K130155 | MUSE CARDIOLOGY INFORMATION SYSTEM | DQK | Substantially Equivalent | |
| K120770 | QT GUARD PLUS ANALYSIS SYSTEM | DPS | Substantially Equivalent | |
| K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | DXQ | Substantially Equivalent | |
| K110132 | MUSE CARDIOLOGY INFORMATION SYSTEM | DQK | Substantially Equivalent | |
| K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | |
| K110266 | MAC 5500 HD, MAC 3500 | DPS | Substantially Equivalent | |
| K103678 | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM | DQK | Substantially Equivalent | |
| K103432 | UNITY NETWORK ID | MWI | Substantially Equivalent | |
| K102426 | CARESCAPE MODEL V100 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K092369 | 12SL ECG ANALYSIS PROGRAM | MHX | Substantially Equivalent | |
| K093141 | MARS HOLTER ANALYSIS WORKSTATION | DQK | Substantially Equivalent | |
| K092027 | CARESCAPE MONITOR B850 | MHX | Substantially Equivalent | |
| K091594 | HEART-EXERCISE | MHX | Substantially Equivalent | |
| K090702 | MODIFICATION TO DASH 2500 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K083750 | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM | MHX | Substantially Equivalent | |
| K083639 | MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE | DQK | Substantially Equivalent | |
| K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM | DSA | Substantially Equivalent | |
| K081437 | MAC 1600 ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | |
| K080251 | APEXPRO TELEMETRY SYSTEMS | MHX | Substantially Equivalent | |
| K080157 | DASH 2500 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K073462 | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES | MHX | Substantially Equivalent | |
| K073203 | CARESCAPE V100 | MHX | Substantially Equivalent | |
| K072502 | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM | DQK | Substantially Equivalent | |
| K071982 | MODIFICATION TO: UNITY NETWORK ID | MWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1651104 | 3002737156 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | 465 PAN AMERICAN DR STE 11, EL PASO, TX 79907 US | 2026 | and 29 more, listed in full below |
| 3001570235 | 3001570235 | GE Medical Systems Information Technologies, Inc. | 3114 N Grandview Blvd, Waukesha, WI 53188 US | 2026 | and 30 more, listed in full below |
| 3012359877 | 3012359877 | GE Medical Systems Information Technologies, Inc. | 9900 Innovation Drive, Wauwatosa, WI 53226 US | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBTArterial Blood Sampling Kit
- MKJAutomated External Defibrillators (Non-Wearable)
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- BZLComputer, Oxygen-Uptake
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DXKEchocardiograph
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- DRXElectrode, Electrocardiograph
- DPWFlowmeter, Blood, Cardiovascular
- GWQFull-Montage Standard Electroencephalograph
- HEMImager, Ultrasonic Obstetric-Gynecologic
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- KXOMonitor, Pressure, Intrauterine
- MLDMonitor, St Segment With Alarm
- KNGMonitor, Ultrasonic, Fetal
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- MMAOximeter, Fetal Pulse
- MUDOximeter, Tissue Saturation
- KRBProbe, Thermodilution
- DSFRecorder, Paper Chart
- BZKSpirometer, Monitoring (W/Wo Alarm)
- GWJStimulator, Auditory, Evoked Response
- KOIStimulator, Nerve, Peripheral, Electric
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
Showing 25 of 43| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3039-2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. | Class II | Open, Classified | |
| Z-3038-2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. | Class II | Open, Classified | |
| Z-3037-2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. | Class II | Open, Classified | |
| Z-3036-2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. | Class II | Open, Classified | |
| Z-2878-2026 | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 | Portrait Core Services Software version V1.2.0 Security Vulnerability | Class II | Open, Classified | |
| Z-2876-2026 | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient. | Class II | Open, Classified | |
| Z-2247-2026 | GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2246-2026 | GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2245-2026 | GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2244-2026 | GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2243-2026 | GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2242-2026 | GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | Class II | Open, Classified | |
| Z-2279-2026 | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury. | Class II | Open, Classified | |
| Z-1938-2025 | MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. | The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data. | Class II | Open, Classified | |
| Z-2258-2024 | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ). | Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms. | Class II | Open, Classified | |
| Z-2027-2024 | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX. | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | Class II | Open, Classified | |
| Z-2613-2023 | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. | Class II | Open, Classified | |
| Z-0487-2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station. | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart. | Class II | Terminated | |
| Z-0202-2018 | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. | Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. | Class II | Terminated | |
| Z-0631-2010 | GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software) | Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do | Terminated | ||
| Z-0519-2008 | GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems | Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors. | Terminated | ||
| Z-1134-2007 | GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA | GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows. | Terminated | ||
| Z-1133-2007 | GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA. | GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows. | Terminated | ||
| Z-1132-2007 | GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA. | GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows. | Terminated | ||
| Z-0280-2008 | GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies, Inc., Milwaukee, Wisconsin (System hardware consists of a processing unit and a monitor) | Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain