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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems China Co., Ltd.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1631-2025

Related Recalls

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

May 16, 2025 Diagnostic Equipment View Details →

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

May 16, 2025 Diagnostic Equipment View Details →
Class I - Dangerous

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.

Mar 21, 2025 Other Medical Devices Nationwide View Details →