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: 648 units Lot/code info: GTIN 00195278439529, Serial Numbers: SM724450001MD, SM724450002MD, SM724450003MD, SM724450004MD, SM724450005MD, SM724450006MD, SM724450007MD, SM724450008MD, SM724450009MD, SM724450010MD, SM724450011MD, SM724450012MD, SM724450013MD, SM724450005WD, SM724450006WD, SM724450007WD, SM724450008WD, SM724450009WD, SM724450010WD, SM724450011WD, SM724450012WD, SM724450017WD, SM725030187WD, SM725030188WD, SM724320011WD, SM724320012WD, SM724320013WD, SM725030189WD, SM725030190WD, SM723290013WD, SM725020154WD, SM725020153WD, SM724390001WD, SM724390002WD, SM724390003WD, SM724390004WD, SM724360007WD, SM724360008WD, SM724360009WD, SM724510130WD, SM724510131WD, SM725030196WD, SM725030197WD, SM725030198WD, SM725020152WD, SM724490117WD, SM725010144WD, SM724190036WD, SM724190031WD, SM724190032WD, SM724190033WD, SM724190034WD, SM724190035WD, SM724190027WD, SM724190028WD, SM724190029WD, SM724190030WD, SM723290017WD, SM724190038WD, SM724200003WD, SM724200001WD, SM724190039WD, SM724200002WD, SM724190037WD, SM724460035WD, SM724450001WD, SM724330006WD, SM724320001WD, SM724320016WD, SM724320017WD, SM724320018WD, SM724320019WD, SM724320020WD, SM724320021WD, SM724320022WD, SM724320023WD, SM724320024WD, SM724320025WD, SM724320026WD, SM724320027WD, SM724320028WD, SM724320029WD, SM724320030WD, SM724220002WD, SM724220003WD, SM724220004WD, SM724220005WD, SM724220006WD, SM724220008WD, SM724220007WD, SM724220010WD, SM724180014WD, SM724200001MD, SM724200002MD, SM724200003MD, SM724210001MD, SM724210002MD, SM724210
00195278439529
Official record: FDA (Device enforcement) ↗
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