CLASS I ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

GE Healthcare Carestation 650 A1 recalled by GE Medical Systems China Co

GE Medical Systems China is recalling GE Healthcare Carestation 650 A1, distributed nationwide in the US. The recall was initiated on 21 Mar 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 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, SM724410004WD, SM724410005WD, SM724170011WD, SM724390016WD, SM724390017WD, SM724330008WD, SM725020177WD, SM724340022WD, SM724320043WD, SM724460019WD, SM724320041WD, SM724320042WD, SM724410002WD, SM724460002WD, SM724330001WD, SM724330002WD, SM724330003WD, SM724330007WD, SM724220009WD, SM724290027WD, SM724290028WD, SM724270003WD, SM724340011WD, SM724170010WD, SM724210018WD, SM724460021WD, SM724460022WD, SM724340020WD, SM724340021WD, SM724340010WD, SM724210012WD, SM724190024WD, SM724190025WD, SM725020161WD, SM725020162WD, SM724340012WD, SM724290001WD, SM724290002WD, SM724210011WD, SM724460003WD, SM724330011WD, SM724330012WD, SM724470074WD, SM724330016WD, SM724460054WD, SM724350002WD, SM724350003WD, SM724410001WD, SM724370001WD, SM724450002WD, SM724450003WD, SM724450004WD, SM724290025WD, SM724290026WD, SM724170004WD, SM724170005WD, SM724290024WD, SM724170012WD, SM724320010WD, SM724460007WD, SM724500128WD, SM724410006WD, SM724410007WD, SM724350004WD, SM724190015WD, SM724190018WD, SM724320006WD, SM724320007WD, SM724320008WD, SM724370003WD, SM724170006WD, SM724210016WD, SM724470077WD, SM724470078WD, SM724190020WD, SM724190021WD, SM724170013WD, SM724210017WD, SM724320014WD, SM724460018WD, SM724500125WD, SM724370002WD, SM724340023WD, SM724340024WD, SM725070238WD, SM725070239WD, SM725070240WD, SM724480099WD, SM724510129WD, SM725010149WD, SM724490116WD, SM725070242WD, SM724210010WD, SM723300001MD, SM723300002MD, SM725050152MD, SM724390005WD, SM724390006WD, SM724390007WD, SM724390008WD, SM724390009WD, SM724390010WD, SM724390011WD, SM724390012WD, SM724390013WD, SM724390014WD, SM724500033MD, SM724500034MD, SM725030093MD, SM724500120WD, SM724500121WD, SM724500122WD, SM724500123WD, SM725030211WD, SM725030212WD, SM725020151WD, SM724360011WD, SM724340009WD, SM724360010WD, SM724340014WD, SM724340015WD, SM724330004WD, SM724470076WD, SM724360002WD, SM724370004WD, SM724290004WD, SM724290005WD, SM724480100WD, SM724480101WD, SM724480102WD, SM724480103WD, SM724480105WD, 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, SM724460055WD, SM724510136WD, SM724510137WD, SM724460037WD, SM724460034WD, SM724240001WD, SM724240002WD, SM724240003WD, SM724470079WD, SM724470080WD, SM724470081WD, SM724470082WD, SM724470083WD, SM724470084WD, SM724470085WD, SM724470086WD, SM724470087WD, SM724470088WD, SM724470090WD, SM724470091WD, SM724230001WD, SM724450016WD, SM724290007WD, SM724290008WD, SM724200006WD, SM724200007WD, SM724330013WD, SM724330014WD, SM724470058WD, SM724510037MD, SM724510038MD, SM724510039MD, SM724510040MD, SM724510041MD, SM724510042MD, SM724440001MD, SM724440002MD, SM725030136MD, SM725030137MD, SM724450021WD, SM724450022WD, SM724450023WD, SM724450024WD, SM724450025WD, SM724450026WD, SM724450027WD, SM724450028WD, SM724450029WD, SM724450030WD, SM724450031WD, SM724450032WD, SM724450033WD, SM724450034WD, SM724450035WD, SM724450036WD, SM724450037WD, SM724450038WD, SM724450039WD, SM724450040WD, SM723300003MD, SM723300004MD, SM723300007MD, SM723300008MD, SM723300009MD, SM724510043MD, SM724510044MD, 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, SM724340004WD, SM724340005WD, SM724340006WD, SM724340007WD, SM724380003WD, SM724380004WD, SM724410008WD, SM724410009WD, SM724410010WD, SM724410011WD, SM724410012WD, SM724410013WD, SM724470095WD, SM724470094WD, SM725030202WD, SM725030203WD, SM725030204WD, SM725030205WD, SM725030206WD, SM725030207WD, SM725030208WD, SM725030209WD, SM724290006WD, SM724210004WD, SM724210005WD, SM724210006WD, SM724190040WD, SM724190041WD, SM724450013WD, SM724450014WD, SM724450015WD, SM724190042WD, SM724190043WD, SM723290005WD, SM723290026WD, SM724450019WD, SM724450020WD, SM724470097WD, SM724480108WD, SM724480109WD, SM724480110WD, SM724480111WD, SM724480112WD, SM724480113WD, SM724450041WD, SM724450042WD, SM724450043WD, SM724450044WD, SM724450045WD, SM724450046WD, SM724480098WD, SM724450047WD, SM724450048WD, SM724210001WD, SM724210002WD, SM724210003WD, SM724320001MD.

Quantity recalled648 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1631-2025
FDA event ID: 96634
Recalling firm: GE Medical Systems China, Wuxi
Classification: Class I
Status: Ongoing
Recall initiated: 21 Mar 2025
FDA classified: 29 Apr 2025
Reported: 7 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Mar 2025	Recall initiated by company
29 Apr 2025	Classified by FDA	+39 days
7 May 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.

Where it was distributed

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, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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, SM724410004WD, SM724410005WD, SM724170011WD, SM724390016WD, SM724390017WD, SM724330008WD, SM725020177WD, SM724340022WD, SM724320043WD, SM724460019WD, SM724320041WD, SM724320042WD, SM724410002WD, SM724460002WD, SM724330001WD, SM724330002WD, SM724330003WD, SM724330007WD, SM724220009WD, SM724290027WD, SM724290028WD, SM724270003WD, SM724340011WD, SM724170010WD, SM724210018WD, SM724460021WD, SM724460022WD, SM724340020WD, SM724340021WD, SM724340010WD, SM724210012WD, SM724190024WD, SM724190025WD, SM725020161WD, SM725020162WD, SM724340012WD, SM724290001WD, SM724290002WD, SM724210011WD, SM724460003WD, SM724330011WD, SM724330012WD, SM724470074WD, SM724330016WD, SM724460054WD, SM724350002WD, SM724350003WD, SM724410001WD, SM724370001WD, SM724450002WD, SM724450003WD, SM724450004WD, SM724290025WD, SM724290026WD, SM724170004WD, SM724170005WD, SM724290024WD, SM724170012WD, SM724320010WD, SM724460007WD, SM724500128WD, SM724410006WD, SM724410007WD, SM724350004WD, SM724190015WD, SM724190018WD, SM724320006WD, SM724320007WD, SM724320008WD, SM724370003WD, SM724170006WD, SM724210016WD, SM724470077WD, SM724470078WD, SM724190020WD, SM724190021WD, SM724170013WD, SM724210017WD, SM724320014WD, SM724460018WD, SM724500125WD, SM724370002WD, SM724340023WD, SM724340024WD, SM725070238WD, SM725070239WD, SM725070240WD, SM724480099WD, SM724510129WD, SM725010149WD, SM724490116WD, SM725070242WD, SM724210010WD, SM723300001MD, SM723300002MD, SM725050152MD, SM724390005WD, SM724390006WD, SM724390007WD, SM724390008WD, SM724390009WD, SM724390010WD, SM724390011WD, SM724390012WD, SM724390013WD, SM724390014WD, SM724500033MD, SM724500034MD, SM725030093MD, SM724500120WD, SM724500121WD, SM724500122WD, SM724500123WD, SM725030211WD, SM725030212WD, SM725020151WD, SM724360011WD, SM724340009WD, SM724360010WD, SM724340014WD, SM724340015WD, SM724330004WD, SM724470076WD, SM724360002WD, SM724370004WD, SM724290004WD, SM724290005WD, SM724480100WD, SM724480101WD, SM724480102WD, SM724480103WD, SM724480105WD, 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, SM724460055WD, SM724510136WD, SM724510137WD, SM724460037WD, SM724460034WD, SM724240001WD, SM724240002WD, SM724240003WD, SM724470079WD, SM724470080WD, SM724470081WD, SM724470082WD, SM724470083WD, SM724470084WD, SM724470085WD, SM724470086WD, SM724470087WD, SM724470088WD, SM724470090WD, SM724470091WD, SM724230001WD, SM724450016WD, SM724290007WD, SM724290008WD, SM724200006WD, SM724200007WD, SM724330013WD, SM724330014WD, SM724470058WD, SM724510037MD, SM724510038MD, SM724510039MD, SM724510040MD, SM724510041MD, SM724510042MD, SM724440001MD, SM724440002MD, SM725030136MD, SM725030137MD, SM724450021WD, SM724450022WD, SM724450023WD, SM724450024WD, SM724450025WD, SM724450026WD, SM724450027WD, SM724450028WD, SM724450029WD, SM724450030WD, SM724450031WD, SM724450032WD, SM724450033WD, SM724450034WD, SM724450035WD, SM724450036WD, SM724450037WD, SM724450038WD, SM724450039WD, SM724450040WD, SM723300003MD, SM723300004MD, SM723300007MD, SM723300008MD, SM723300009MD, SM724510043MD, SM724510044MD, 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, SM724340004WD, SM724340005WD, SM724340006WD, SM724340007WD, SM724380003WD, SM724380004WD, SM724410008WD, SM724410009WD, SM724410010WD, SM724410011WD, SM724410012WD, SM724410013WD, SM724470095WD, SM724470094WD, SM725030202WD, SM725030203WD, SM725030204WD, SM725030205WD, SM725030206WD, SM725030207WD, SM725030208WD, SM725030209WD, SM724290006WD, SM724210004WD, SM724210005WD, SM724210006WD, SM724190040WD, SM724190041WD, SM724450013WD, SM724450014WD, SM724450015WD, SM724190042WD, SM724190043WD, SM723290005WD, SM723290026WD, SM724450019WD, SM724450020WD, SM724470097WD, SM724480108WD, SM724480109WD, SM724480110WD, SM724480111WD, SM724480112WD, SM724480113WD, SM724450041WD, SM724450042WD, SM724450043WD, SM724450044WD, SM724450045WD, SM724450046WD, SM724480098WD, SM724450047WD, SM724450048WD, SM724210001WD, SM724210002WD, SM724210003WD, SM724320001MD.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 96634

This product is part of a recall event; the main page for the event is GE Healthcare Carestation 620 A2 recalled by GE Medical Systems China Co.

Reported	Class	Recall	Company	Reason	Where
7 May 2025	CLASS I	GE Healthcare Carestation 620 A2 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650C A1 recalled	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 750 A2 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650 SE recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 620 A1 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650 A2 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650C A2 recalled	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 620 SE recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 750c A2 recalled	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650 A1 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 750 A1 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 620 A1 recalled by GE Medical Systems China Co	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 750c A1 recalled	GE Medical Systems China	Other	Nationwide
7 May 2025	CLASS I	GE Healthcare Carestation 650c A1 recalled	GE Medical Systems China	Other	Nationwide

More recalls from GE Medical Systems China

All 25

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	MAC 5 A4 Resting ECG Analysis System recalled	GE Medical Systems China	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS I	GE Healthcare Carestation anesthesia system Power recalled	GE Medical Systems China	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS I	GE Healthcare Carestation anesthesia system, product number recalled	GE Medical Systems China	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS I	GE Healthcare Carestation anesthesia system, product number recalled	GE Medical Systems China	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	GE Healthcare Logiq F R3 Ultrasound System recalled	GE Medical Systems China	Other

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide