GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.

Summary

The FDA issued a Class I for GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia sys by GE Medical Systems China Co., Ltd.. Reason: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) m.

Details

Product Description

GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.

Lot/Code Info: GTIN 00840682124560, Serial Numbers: SM723010002WB, SM723010003WB, SM723010004WB, SM723010005WB, SM723010001WB, SM724010002WB, SM724010003WB, SM724010004WB, SM724010005WB, SM724010006WB, SM724010007WB, SM724010008WB, SM724010009WB, SM724010010WB, SM724010011WB, SM724010012WB, SM724010013WB, SM724010014WB, SM724480168WB, SM724480169WB, SM724480170WB, SM724480171WB, SM724480172WB, SM724480173WB, SM724480174WB, SM724410162WB, SM723500005WB, SM723500006WB, SM723500007WB, SM723500008WB, SM723500009WB, SM723500020WB, SM723500021WB, SM723500022WB, SM723500023WB, SM723500024WB, SM723510007WB, SM723510008WB, SM723510009WB, SM723510010WB, SM723510011WB, SM723510012WB, SM723510013WB, SM723510014WB, SM723510015WB, SM723510016WB, SM723510017WB, SM723510018WB, SM723510019WB, SM723510020WB, SM723510021WB, SM724370096WB, SM724370097WB, SM724370098WB, SM724370099WB, SM724370100WB, SM724370101WB, SM724370102WB, SM724370103WB, SM724370104WB, SM724370105WB, SM724370106WB, SM724370107WB, SM723340001WB, SM724320072WB, SM724370093WB, SM724340086WB, SM724340087WB, SM724340088WB, SM724340089WB, SM723500010WB, SM723500011WB, SM723500012WB, SM723500013WB, SM723500014WB, SM723500015WB, SM723500016WB, SM723500017WB, SM723500018WB, SM723500019WB, SM724370094WB, SM724370095WB, SM724370092WB, SM723080001WB, SM723080007WB, SM723080008WB, SM723080009WB, SM723080010WB, SM723080011WB, SM723080012WB, SM723080013WB, SM723080014WB, SM723080015WB, SM723510029WB, SM724250020WB, SM724250021WB, SM724250022WB, SM724250023WB, SM724250024WB, SM724250025WB, SM724250026WB, SM724250028WB, SM724250029WB, SM723460077WB, SM723480003WB, SM723240030WB, SM724250027WB, SM723460097WB, SM723460098WB, SM724380113WB, SM724380114WB, SM723240001WB, SM725030313WB, SM723440074WB, SM723440075WB, SM723440076WB, SM725030312WB, SM723130010WB, SM723130011WB, SM723130012WB, SM723180003WB, SM723180004WB, SM723430067WB, SM724010001WB, SM723390065WB, SM723390066WB, SM723240010WB, SM723240011WB, SM723240012WB, SM723240013WB, SM723240014WB, SM723240015WB, SM723240016WB, SM723240017WB, SM723240018WB, SM723240019WB, SM723240020WB, SM723240021WB, SM723240022WB, SM723240023WB, SM723240024WB, SM723240025WB, SM723240026WB, SM723240027WB, SM723240028WB, SM724110009WB, SM723470099WB, SM724120036WB, SM724120037WB, SM724120038WB, SM724120039WB, SM724120040WB, SM724120041WB, SM724240012WB, SM724240014WB, SM724460164WB, SM724460165WB, SM724460166WB, SM724460167WB, SM724120009WB, SM723240031WB, SM723240032WB, SM723460093WB, SM723460094WB, SM723460095WB, SM723460096WB, SM723510001WB, SM724120013WB, SM724120014WB, SM724250030WB, SM724250031WB, SM724250032WB, SM724250033WB, SM724250034WB, SM724250035WB, SM724510266WB, SM724510267WB, SM724510268WB, SM724510269WB, SM724110005WB, SM724110007WB, SM724110008WB, SM724110011WB, SM724110012WB, SM724110013WB, SM724110014WB, SM724510256WB, SM724510257WB, SM724510258WB, SM724510259WB, SM724510260WB, SM724510261WB, SM724510262WB, SM724510263WB, SM724510264WB, SM724510265WB, SM723240029WB, SM724120011WB, SM724120012WB, SM723240009WB, SM723370054WB, SM723240004WB, SM723240005WB, SM723240006WB, SM723240007WB, SM723240008WB, SM724110006WB, SM724120010WB, SM723460088WB, SM723460089WB, SM723460090WB, SM723500001WB, SM723500002WB, SM723500003WB, SM723510002WB, SM723510003WB, SM724370108WB, SM724370109WB, SM724370110WB, SM724370111WB, SM724370112WB, SM724380128WB, SM724380129WB, SM724380130WB, SM724380131WB, SM724380132WB, SM724110010WB, SM723350004WB, SM723350020WB, SM723350021WB, SM723460091WB, SM723460092WB, SM723250033WB, SM723250034WB, SM723250036WB, SM723250038WB, SM723250039WB, SM723310005WB, SM723310007WB, SM723310008WB, SM723310009WB, SM723120001WB, SM723120002WB, SM723120003WB, SM723120004WB, SM723120005WB, SM723350005WB, SM723350006WB, SM723350007WB, SM723350008WB, SM723350009WB, SM723350010WB, SM723350011WB, SM723350012WB, SM723350013WB, SM723350014WB, SM723350015WB, SM723510004WB, SM723510005WB, SM723510006WB, SM724510229WB, SM724510230WB, SM724510231WB, SM724510232WB, SM724510233WB, SM724510234WB, SM724510235WB, SM724510236WB, SM724510237WB, SM724510251WB, SM724510252WB, SM724510253WB, SM724510254WB, SM724510255WB, SM723510024WB, SM723510025WB, SM723510026WB, SM723510027WB, SM723510028WB, SM723310006WB, SM723510022WB, SM723250035WB, SM723510023WB, SM724510228WB, SM723310004WB, SM724110001WB, SM724110002WB, SM724510248WB, SM724510249WB, SM724510250WB, SM723510036WB, SM723510037WB, SM723510038WB, SM723510039WB, SM723510040WB, SM723510041WB, SM723510042WB, SM723510043WB, SM723510044WB, SM723350022WB, SM723280001WB, SM723280002WB, SM723280006WB, SM723280003WB, SM723280004WB, SM723280005WB, SM723050001WB, SM723050002WB, SM723370049WB, SM723370050WB, SM723370051WB, SM723370052WB, SM723370053WB, SM723470100WB, SM723470101WB, SM723470102WB, SM723470103WB, SM723470104WB, SM723470105WB, SM723470106WB, SM723470107WB, SM723470108WB, SM723470109WB, SM723470110WB, SM723470111WB, SM723370055WB, SM723370056WB, SM724120034WB, SM724110015WB, SM724110016WB, SM724110017WB, SM723180001WB, SM723180002WB, SM724490180WB, SM724490181WB, SM724490182WB, SM724490183WB, SM723250037WB, SM723350023WB, SM723350024WB, SM723350025WB, SM723350026WB, SM723350027WB, SM723350028WB, SM723350029WB, SM724380125WB, SM724380126WB, SM724380127WB, SM724380133WB, SM724380134WB, SM723110001WB, SM723380059WB, SM723230034WB, SM723230035WB, SM723230032WB, SM723230033WB, SM723230036WB, SM723230037WB, SM723380064WB, SM723380062WB, SM723380063WB, SM723380060WB, SM723380061WB, SM724250015WB, SM724250016WB, SM724250017WB, SM724250018WB, SM723210001WB, SM723210002WB, SM723210003WB, SM723210004WB, SM723210005WB, SM723210006WB, SM724250019WB, SM723160002WB, SM723160003WB, SM723510035WB, SM723370057WB, SM723370058WB, SM723040001WB, SM724360091WB, SM723240045WB, SM723240046WB, SM724230011WB, SM724120042WB, SM724120043WB, SM724120044WB, SM724120045WB, SM724120046WB, SM723440068WB, SM723440069WB, SM723080016WB, SM725040315WB, SM724510194WB, SM724510195WB, SM723500004WB, SM723110013WB, SM723110014WB, SM723110015WB, SM724070001WB, SM724070002WB, SM724080001WB, SM724080002WB, SM724080003WB, SM724080004WB, SM724080005WB, SM724080006WB, SM724290070WB, SM724290071WB, SM723360039WB, SM723360040WB, SM723360041WB, SM723360042WB, SM723150001WB, SM724090008WB, SM723020001WB, SM723020002WB, SM723020003WB, SM723020004WB, SM723020005WB, SM724090003WB, SM724090004WB, SM724090005WB, SM724090006WB, SM724090007WB, SM723060003WB, SM723060004WB, SM723060005WB, SM723060001WB, SM723060002WB, SM725030314WB, SM724190002WB, SM723440070WB, SM723440071WB, SM723440072WB, SM723440073WB, SM723480001WB, SM723480002WB, SM724190001WB, SM724190003WB, SM724110003WB, SM724110004WB, SM724210007WB, SM724210008WB, SM723060006WB, SM723060007WB, SM723060008WB, SM723060009WB, SM723100001WB, SM723100003WB, SM723100004WB, SM724210009WB, SM724210010WB, SM724260060WB, SM724260061WB, SM724260062WB, SM723360030WB, SM724510201WB, SM724510202WB, SM724510203WB, SM724510204WB, SM724510205WB, SM723360033WB, SM723230038WB, SM723230039WB, SM723370046WB, SM724120021WB, SM724210004WB, SM724210005WB, SM724210006WB, SM724250036WB, SM724250037WB, SM724250058WB, SM724250059WB, SM724330073WB, SM724330074WB, SM724330075WB, SM724330076WB, SM724330077WB, SM724330078WB, SM724330079WB, SM724330080WB, SM724330081WB, SM724330082WB, SM724330083WB, SM724330084WB, SM724330085WB, SM723220001WB, SM723220002WB, SM724490179WB, SM723190001WB, SM723360034WB, SM724120019WB, SM724120020WB, SM723190003WB, SM724090002WB, SM723370043WB, SM723370044WB, SM723370045WB, SM723080017WB, SM723080018WB, SM723080019WB, SM723080020WB, SM723360036WB, SM723360037WB, SM723360038WB, SM723360031WB, SM723360032WB, SM724090001WB, SM724460163WB, SM723360035WB, SM723370047WB, SM724480175WB, SM724480176WB, SM724480177WB, SM724480178WB, SM723100005WB, SM723370048WB, SM724100002WB, SM724120018WB, SM723190002WB, SM723080002WB, SM723080003WB, SM723080004WB, SM723080005WB, SM723080006WB, SM724120016WB, SM724120017WB, SM724120022WB, SM724120026WB, SM724120030WB, SM724120032WB, SM724120033WB, SM723250002WB, SM723250003WB, SM723250004WB, SM723250005WB, SM724120015WB, SM724120023WB, SM724120024WB, SM724120025WB, SM724120027WB, SM724120028WB, SM724120029WB, SM724120031WB, SM724120035WB, SM723250001WB, SM723250006WB, SM724040001WB, SM724020001WB, SM724020002WB, SM723310001WB, SM723110003WB, SM724250056WB, SM724250057WB, SM724510214WB, SM724510215WB, SM724510216WB, SM724510217WB, SM724510218WB, SM724510219WB, SM724510220WB, SM724510221WB, SM724510222WB, SM724510223WB, SM724510224WB, SM724510225WB, SM724510226WB, SM724510227WB, SM724380117WB, SM724380121WB, SM724380124WB, SM723110017WB, SM723110018WB, SM723110019WB, SM724250052WB, SM724250053WB, SM724250054WB, SM724250055WB, SM724510206WB, SM724510207WB, SM724510208WB, SM724510209WB, SM724510210WB, SM724510211WB, SM724510212WB, SM724510213WB, SM723110020WB, SM723110021WB, SM723110022WB, SM723110023WB, SM723110024WB, SM723110025WB, SM723110026WB, SM723230001WB, SM723230002WB, SM723230004WB, SM723230014WB, SM723230015WB, SM723230016WB, SM723230017WB, SM723230018WB, SM723110027WB, SM723230030WB, SM723230031WB, SM723510030WB, SM723510031WB, SM723510032WB, SM723510033WB, SM723510034WB, SM723230003WB, SM723230005WB, SM723230006WB, SM723230007WB, SM723230008WB, SM723230009WB, SM723230010WB, SM723230011WB, SM723230012WB, SM723230013WB, SM724250038WB, SM724250039WB, SM724250040WB, SM724250041WB, SM724250042WB, SM724250043WB, SM724250044WB, SM724250045WB, SM724250046WB, SM724250047WB, SM724250048WB, SM724250049WB, SM724250050WB, SM724250051WB, SM724380115WB, SM724380116WB, SM724380118WB, SM724380119WB, SM724380120WB, SM724380122WB, SM724380123WB, SM723110002WB, SM723110004WB, SM723110005WB, SM723110006WB, SM723110007WB, SM723110008WB, SM723230019WB, SM723230020WB, SM723230021WB, SM723230022WB, SM723230023WB, SM723230024WB, SM723230025WB, SM723230026WB, SM723230027WB, SM723230028WB, SM723230029WB, SM723110016WB, SM723110009WB, SM723110010WB, SM723110011WB, SM723110012WB, SM723240002WB, SM723240003WB, SM723350016WB, SM723350017WB, SM723350018WB, SM723350019WB, SM724090010WB, SM724120002WB, SM723460082WB, SM723460078WB, SM723460079WB, SM723460080WB, SM723460081WB, SM723120006WB, SM723120007WB, SM723120008WB, SM723120009WB, SM723460084WB, SM723460085WB, SM724120004WB, SM724120005WB, SM724090009WB, SM724120003WB, SM724120006WB, SM724120007WB, SM724120008WB, SM724510198WB, SM724510199WB, SM724510200WB, SM724510238WB, SM724510239WB, SM724510240WB, SM724510241WB, SM724510242WB, SM724510243WB, SM724510244WB, SM724510245WB, SM724510246WB, SM724510247WB, SM724510196WB, SM724510197WB, SM723460083WB, SM723460087WB, SM723460086WB, SM724120001WB, SM723160001WB, SM723310002WB, SM724390152WB, SM724390153WB, SM724390155WB, SM724390156WB, SM724390157WB, SM724390158WB, SM724390159WB, SM724510184WB, SM724510185WB, SM724510186WB, SM724510187WB, SM724510188WB, SM724510189WB, SM724510190WB, SM724510191WB, SM724510192WB, SM724510193WB, SM724520270WB, SM724520271WB, SM724520272WB, SM724520273WB, SM724520274WB, SM724520275WB, SM724520276WB, SM724520277WB, SM724520278WB, SM724520279WB, SM724390137WB, SM724390138WB, SM724390139WB, SM724390140WB, SM724390141WB, SM724390142WB, SM724390143WB, SM724390144WB, SM724390145WB, SM724390146WB, SM724390147WB, SM724390148WB, SM724390149WB, SM724390150WB, SM724390151WB, SM724260067WB, SM724260068WB, SM724260063WB, SM724260064WB, SM724260065WB, SM724260069WB, SM723240041WB, SM723160004WB, SM723340002WB, SM723340003WB, SM723240040WB, SM723240043WB, SM723240042WB, SM723240044WB, SM724520280WB, SM724520281WB, SM724520282WB, SM724520283WB, SM724520284WB, SM724520285WB, SM724520286WB, SM724520287WB, SM724520288WB, SM724520289WB, SM724520290WB, SM724520291WB, SM724520292WB, SM724520293WB, SM724520294WB, SM724520295WB, SM724520296WB, SM724520297WB, SM724520298WB, SM724520299WB, SM724520300WB, SM724520301WB, SM724520302WB, SM724520303WB, SM724520304WB, SM724520305WB, SM724520306WB, SM724520307WB, SM724520308WB, SM724520309WB, SM724520310WB, SM724520311WB, SM724380135WB, SM724380136WB, SM724030001WB, SM724260066WB, SM724160001WB, SM724160003WB, SM724390154WB, SM724390160WB, SM724390161WB, SM723090024WB, SM723090025WB, SM724060002WB, SM724160002WB, SM724030002WB, SM724060001WB, SM723090026WB, SM723310003WB.

Quantity Affected: 815 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-21

Company