GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

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, SM724210003MD, SM724210004MD, SM724210005MD, SM724410002MD, SM724270002WD, SM724450049WD, SM724450050WD, SM724450051WD, SM724450052WD, SM724470056WD, SM724470057WD, SM724470059WD, SM724470060WD, SM724470061WD, SM724470062WD, SM724470063WD, SM724470064WD, SM724470065WD, SM724470066WD, SM723300005MD, SM723300006MD, SM724480020MD, SM724480021MD, SM724480022MD, SM724480023MD, SM724480024MD, SM724480025MD, SM724480026MD, SM724480027MD, SM724480028MD, SM724480029MD, SM724480030MD, SM724480031MD, SM724480032MD, SM725020068MD, SM725020069MD, SM725020070MD, SM725020071MD, SM725020072MD, SM725020078MD, SM725020079MD, SM725020080MD, SM725020081MD, SM725020082MD, SM724460024WD, SM724320004WD, SM723290002WD, SM723290003WD, SM724460032WD, SM724470071WD, SM724150002WD, SM724460013WD, SM724520143WD, SM724460053WD, SM724470096WD, SM724510135WD, SM724490115WD, SM724360003WD, SM724360004WD, SM724360005WD, SM724360006WD, SM724360016WD, SM724410003WD, SM724460038WD, SM724460039WD, SM724460040WD, SM724460041WD, SM724460042WD, SM724460043WD, SM724460044WD, SM724460045WD, SM724460046WD, SM724460047WD, SM724460048WD, SM724460049WD, SM724460050WD, SM724460051WD, SM724460052WD, SM724500124WD, SM724510134WD, SM724520141WD, SM724520142WD, SM725020166WD, SM724150001WD, SM724340016WD, SM724340017WD, SM725040138MD, SM725040139MD, SM725040141MD, SM725040140MD, SM725030210WD, SM724450014MD, SM724450015MD, SM724450016MD, SM724450017MD, SM724450018MD, SM725030119MD, SM725030120MD, SM725030121MD, SM725030122MD, SM725030123MD, SM725030124MD, SM725030125MD, SM725030126MD, SM725030127MD, SM725030128MD, SM725030129MD, SM725030130MD, SM725030131MD, SM725030132MD, SM725030133MD, SM725050142MD, SM725050143MD, SM725050144MD, SM725050145MD, SM725050146MD, SM725040216WD, SM725040217WD, SM725040218WD, SM725040219WD, SM725040220WD, SM725040221WD, SM725040222WD, SM725040223WD, SM725040224WD, SM725040225WD, SM725040226WD, SM725040227WD, SM725040228WD, SM725040229WD, SM724460008WD, SM724460009WD, SM724460010WD, SM724470075WD, SM724460011WD, SM724470069WD, SM724470070WD, SM724510132WD, SM724510133WD, SM724330005WD, SM724200004WD, SM724320038WD, SM724320039WD, SM724290015WD, SM724320048WD, SM724320049WD, SM724210013WD, SM724320045WD, SM724460017WD, SM724220001WD, SM724460001WD, SM724460036WD, SM724170007WD, SM724170008WD, SM724470072WD, SM724470073WD, SM724170009WD, SM724270004WD, SM724320002WD, SM724320003WD, SM724340018WD, SM724340013WD, SM724410018WD, SM724330010WD, 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SM724480106WD, SM724320050WD, SM723290016WD, SM724270001WD, SM724360001WD, SM724360012WD, SM724360013WD, SM724360014WD, SM724360015WD, SM724460012WD, SM724470092WD, SM724470093WD, SM724480104WD, SM724380001WD, SM724380002WD, SM724470067WD, SM724470068WD, SM724330015WD, SM724150052MD, SM724150053MD, SM724150054MD, SM724150051MD, SM724150055MD, SM724150056MD, SM724150058MD, SM724150059MD, SM724150060MD, SM724190001MD, SM724190002MD, SM724190003MD, SM724190004MD, SM724190005MD, SM724190006MD, SM724190007MD, SM724190008MD, SM724190009MD, SM724190010MD, SM724190011MD, SM724150057MD, SM724290019WD, SM724290020WD, SM724290021WD, SM724290022WD, SM724290023WD, SM724460025WD, SM724460026WD, SM724460027WD, SM724460028WD, SM724460029WD, SM724460030WD, SM724460031WD, SM724320032WD, SM724320033WD, SM724320034WD, SM724320035WD, SM724320036WD, SM724320037WD, SM724490118WD, SM724490119WD, SM724510138WD, SM724510139WD, SM724510140WD, SM725030201WD, SM724470089WD, SM724460033WD, SM725070241WD, 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SM724510045MD, SM724510046MD, SM724510047MD, SM724510048MD, SM724510049MD, SM724510050MD, SM724510051MD, SM724510052MD, SM724510053MD, SM724510054MD, SM724510055MD, SM724510056MD, SM724510057MD, SM724510058MD, SM724510059MD, SM724510060MD, SM724510061MD, SM724510062MD, SM724510063MD, SM724510064MD, SM724510065MD, SM724510066MD, SM724510067MD, SM725020083MD, SM725020084MD, SM725020085MD, SM725020086MD, SM725020087MD, SM725020088MD, SM725020089MD, SM725020090MD, SM725020091MD, SM725020092MD, SM725030094MD, SM725030095MD, SM725030096MD, SM725030097MD, SM725030098MD, SM725030099MD, SM725030100MD, SM725030101MD, SM725030102MD, SM725030103MD, SM725030104MD, SM725030105MD, SM725030106MD, SM725030107MD, SM725030108MD, SM725030109MD, SM725030110MD, SM725030111MD, SM725030112MD, SM725030113MD, SM725030114MD, SM725030115MD, SM725030116MD, SM725030117MD, SM725030118MD, SM725030134MD, SM725030135MD, SM724190044WD, SM724210008WD, SM724210009WD, SM723290014WD, SM723290015WD, SM724340003WD, 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