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.
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: 27 units Lot/code info: GTIN 00195278569677, Serial Numbers: SM624250018WC, SM624250019WC, SM624500025WC, SM624500026WC, SM624500027WC, SM624290020WC, SM624290021WC, SM623470001WC, SM623470002WC, SM623470003WC, SM623470004WC, SM623470005WC, SM623470006WC, SM623470007WC, SM623470008WC, SM623470009WC, SM623470010WC, SM623470011WC, SM623470012WC, SM624240017WC, SM624240013WC, SM624240014WC, SM624240015WC, SM624240016WC, SM624110001WC, SM624330022WC, SM624330023WC.
00195278569677
Official record: FDA (Device enforcement) ↗
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