GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Summary
The FDA issued a Class I for GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. 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
Source
Device Recall
External ID
Z-1631-2025
Action Date
2025-05-07
Status
Ongoing
Category
device
Product Description
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
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, 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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, 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 Affected: 648 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.
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-21
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems China Co., Ltd. has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems China Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems China Co., Ltd. have FDA actions?
GE Medical Systems China Co., Ltd. has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1631-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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