GE Medical Systems China Co., Ltd.: GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

Hazard

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.

Details from the source

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. 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, Quantity: 1 unit Lot/code info: GTIN 00195278569684, Serial Numbers: SM724370002WC

UPC codes

00195278569684

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.