GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.

FDA device recall Z-1627-2025 · posted 2025-04-29 · Open, Classified

Recall details

Recalling firm

GE Medical Systems China Co., Ltd.

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.

Action taken

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

Status

Open, Classified

Product code

BSZ

Quantity affected

383 units

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria,

Date initiated

2025-03-21

Date posted

2025-04-29

Location

Wuxi, XIN, China

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