[Recalled] GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 — GE HealthCare has become aware that certain Carestation 620/650/650c and 750/75… | FDA 2025-03-21

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: GE HealthCare has become aware that 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.

This Class I recall concerns device products distributed in China and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from GE Medical Systems China Co., Ltd.

• GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system — Class II
• GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems — Class II
• GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 — Class I
• GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 — Class I
• GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 — Class I
• 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 — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.