GE Medical Systems China Co., Ltd. recall records

22 reported ongoing

22 records in this archive. Latest source date Apr 21, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.

Official source for MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001...
FDA device enforcement

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...

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 ...

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada,...

Official source for GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, ...
FDA device enforcement

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, R...

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 ...

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada,...

Official source for GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, ...
FDA device enforcement

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 ...

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada,...

Official source for GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (...
FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound s...
FDA device enforcement

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...

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 ...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Number...
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
FDA device enforcement

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 Press...

Class IReported ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegov...

Official source for GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

Reasons in these listed records

  • 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.
  • 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...
  • 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 clinica...
  • 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 Ventilat...

These examples come from this result page and are not a ranking of every recall reason.

Checking GE Medical Systems China Co., Ltd.

Is there a recall on ge medical systems china co., ltd. right now?

This archive contains 22 records, including 22 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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