GE Medical Systems China Co., Ltd.
WUXI Jiangsu, CN
GE MEDICAL SYSTEMS (CHINA) CO., LTD. appears in FDA device records in WUXI Jiangsu, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 27 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for GE Medical Systems China Co., Ltd. between 2009 and 2017. The busiest year on record is 2013, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171580 | Monitor B125, Monitor B105 | MHX | Substantially Equivalent | |
| K151063 | Monitor B40 | MHX | Substantially Equivalent | |
| K142288 | MAC 800 Resting ECG Analysis System | DPS | Substantially Equivalent | |
| K133576 | MONITOR B40 | MHX | Substantially Equivalent | |
| K130584 | MONITOR B40 | MHX | Substantially Equivalent | |
| K122253 | PROCARE MONITOR B20 | MHX | Substantially Equivalent | |
| K123238 | ACHILLES | MUA | Substantially Equivalent | |
| K120598 | PROCARE MONITOR B40 | MHX | Substantially Equivalent | |
| K103633 | ACHILLES | MUA | Substantially Equivalent | |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | IYN | Substantially Equivalent | |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | IYN | Substantially Equivalent | |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | IYO | Substantially Equivalent | |
| K091164 | GE VENUE 40, MODEL 5324338 | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710602 | 3003513129 | GE MEDICAL SYSTEMS (CHINA) CO., LTD. | NO. 19 CHANGJIANG ROAD, WUXI Jiangsu 214028 CN | 2026 | and 47 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BSFAbsorber, Carbon-Dioxide
- 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)
- PAAAutomated Breast Ultrasound
- QIHAutomated Radiological Image Processing Software
- MUABone Sonometer
- ORTBurst Suppression Detection Software For Electroencephalograph
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DQOCatheter, Intravascular, Diagnostic
- OBJCatheter, Ultrasound, Intravascular
- QEMCerebral Oximeter
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- BZLComputer, Oxygen-Uptake
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- GXYElectrode, Cutaneous
- GWQFull-Montage Standard Electroencephalograph
- BSZGas-Machine, Anesthesia
- FMZIncubator, Neonatal
- OLWIndex-Generating Electroencephalograph Software
- 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)
- MLDMonitor, St Segment With Alarm
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- MUDOximeter, Tissue Saturation
- KRBProbe, Thermodilution
- DSFRecorder, Paper Chart
- OMCReduced- Montage Standard Electroencephalograph
- BZKSpirometer, Monitoring (W/Wo Alarm)
- GWJStimulator, Auditory, Evoked Response
- KOIStimulator, Nerve, Peripheral, Electric
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- ITXTransducer, Ultrasonic, Diagnostic
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- ITOTwister, Brace Setting
- CBKVentilator, Continuous, Facility Use
- FMTWarmer, Infant Radiant
Recall records
Showing 25 of 27| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2306-2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making. | Class II | Open, Classified | |
| Z-0915-2026 | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. | Class I | Open, Classified | |
| Z-0914-2026 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002 | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. | Class I | Open, Classified | |
| Z-0913-2026 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543 | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings. | Class I | Open, Classified | |
| Z-2030-2025 | GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation. | Class II | Open, Classified | |
| Z-2029-2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation. | Class II | Open, Classified | |
| Z-1638-2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1637-2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1636-2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1635-2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1634-2025 | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1633-2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1632-2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1631-2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1630-2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1629-2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1628-2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1627-2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1626-2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1625-2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-1624-2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. | Class I | Open, Classified | |
| Z-2656-2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days. | Class II | Open, Classified | |
| Z-2956-2018 | GE 9100c NXT anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia. | Class II | Terminated | |
| Z-2955-2018 | GE Carestation 30 anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia. | Class II | Terminated | |
| Z-2954-2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain