Open, Classified

GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.

FDA Recall Z-1628-2025 · Posted 2025-04-29

Recalling FirmGE Medical Systems China Co., Ltd.

Recall StatusOpen, Classified

Product CodeBSZ

Date Initiated2025-03-21

Product Quantity4036 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.