GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.

Recall date

March 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1632-2025

FDA classification

Class I

Brand / firm

GE Medical Systems China Co., Ltd.

Sold / distributed

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 Republi…

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.