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GE Healthcare CARESTATION 750c A1, Model/REF Number… recallZ-1637-2025 · GE Medical Systems China Co., Ltd. · initiated Mar 21, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems China Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice on 03/21/2025. The notice explained the safety issue with the device, potential risk, and requested the following actions: The anesthesia system may continue to be used following these instructions: Perform the Ventilation Screening Test specified in Appendix 1 for each affected Carestation system. If the Carestation system passes the Ventilation Screening Test, you can continue to use the device. If the Carestation system fails the Ventilation Screening Test and must be used prior to the system being corrected by GE HealthCare, follow the instructions below: 1. Use the device in accordance with the instructions in the URM with these changes: i. Use only Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) mode to mechanically ventilate a patient. ii. Do not use Volume Control Ventilation (VCV) mode to mechanically ventilate a patient. NOTE: Manual mode of the anesthesia system can be used to provide manual ventilation or allow spontaneous ventilation of the patient. 2. Users are not to use VCV mode on the device until the device has been corrected by GE HealthCare. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions and retain this document for your record. Questions: contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Notice sent on 04/21/25 with updated instructions. Change: Attach a 2 Liter reservoir bag (original) to Attach a reservoir bag (updated)in step 5 of the Ventilation Screening Test in Appendix 1 of the letter. Notice sent on 5/18/26 added additional affected devices for GE HealthCare Urgent Medical Device Correction notification, Field Replaceable Unit (FRU) parts: DRIVER GAS CHECK VALVE ASSY, M1807901-S; Valve Assembly, 3.5cm H2O Drive Gas Check Valve BCG, 2071125-001-S; A180 Ventilator Engine Assembly, 2071117-001-S.

Recall details

Recall number
Z-1637-2025
Status
Open, Classified
Initiated by the company
Mar 21, 2025
Posted by the FDA
Apr 29, 2025
Recalling firm
GE Medical Systems China Co., Ltd.
Quantity
74 units
Product code
BSZ
FDA submissions
K213867
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

GTIN 00840682146425, Serial Numbers: SQT23330001WA, SQT23080006WA, SQT23080007WA, SQT23080008WA, SQT23080009WA, SQT23080010WA, SQT23080011WA, SQT24440011WA, SQT23150001WA, SQT23070001WA, SQT23070002WA, SQT24430006WA, SQT23200001WA, SQT23200002WA, SQT23200003WA, SQT23200004WA, SQT23200005WA, SQT24290003WA, SQT24510015WA, SQT24520016WA, SQT23360008WA, SQT23360002WA, SQT23360003WA, SQT23360004WA, SQT23360005WA, SQT23360006WA, SQT23360007WA, SQT23170001WA, SQT24430007WA, SQT24430008WA, SQT24430009WA, SQT24430010WA, SQT23190004WA, SQT24410005WA, SQT23050001WA, SQT23050002WA, SQT23050003WA, SQT23050004WA, SQT23060001WA, SQT23060002WA, SQT23060003WA, SQT23300002WA, SQT24230002WA, SQT24440012WA, SQT24440013WA, SQT24440014WA, SQT23400001WA, SQT23400002WA, SQT24022000WA, SQT23480001WA, SQT23370002WA, SQT23370007WA, SQT23370004WA, SQT23370006WA, SQT23370005WA, SQT23370001WA, SQT23370003WA, SQT23370008WA, SQT23370009WA, SQT23370010WA, SQT23370011WA, SQT23460001WA, SQT24160001WA, SQT23350001WA, SQT23420001WA, SQT23420002WA, SQT23190001WA, SQT23190002WA, SQT23190003WA, SQT23190005WA, SQT23190006WA, SQT23190007WA, SQT23190008WA, SQT23190009WA.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K213867 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96634).

Sources and updates

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