GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 750 A2
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia systemGTIN 00840682146470217 affected lotsSQS23480001WBSQS23480002WBSQS23480003WBSQS23480004WBSQS23480005WBSQS23500002WBSQS24510072WBSQS24510073WB
+209 more
SQS24510074WBSQS24510075WBSQS24510076WBSQS24250017WBSQS24250018WBSQS24250019WBSQS24370029WBSQS24370030WBSQS24370031WBSQS23510004WBSQS23370007WBSQS23370008WBSQS23370009WBSQS23370010WBSQS23370011WBSQS23370012WBSQS23370013WBSQS23370014WBSQS23370015WBSQS23370016WBSQS23370017WBSQS23370018WBSQS23510005WBSQS23510006WBSQS23510007WBSQS23510008WBSQS23510009WBSQS23510010WBSQS23510011WBSQS24110012WBSQS24110013WBSQS24110014WBSQS24110015WBSQS24110016WBSQS24110017WBSQS24250014WBSQS24250015WBSQS24250016WBSQS24120023WBSQS24120024WBSQS24120025WBSQS24120026WBSQS24120027WBSQS24120028WBSQS23250006WBSQS23470001WBSQS23470002WBSQS23280001WBSQS23280002WBSQS24110001WBSQS24510063WBSQS24510064WBSQS24510065WBSQS23520005WBSQS23250002WBSQS23250003WBSQS23250004WBSQS23090001WBSQS23090002WBSQS24510079WBSQS24510080WBSQS24510081WBSQS24510082WBSQS24510083WBSQS24510084WBSQS24510085WBSQS24510086WBSQS24510087WBSQS24510088WBSQS23250001WBSQS23490003WBSQS23350001WBSQS23350002WBSQS23120001WBSQS23510016WBSQS23510017WBSQS23510018WBSQS23510019WBSQS23510020WBSQS23510021WBSQS23510022WBSQS23510023WBSQS23510024WBSQS24110003WBSQS24110004WBSQS24110005WBSQS24110020WBSQS24110021WBSQS24110022WBSQS23510012WBSQS23510013WBSQS23510014WBSQS23510015WBSQS24370032WBSQS24370033WBSQS24370034WBSQS24370035WBSQS24370036WBSQS24370037WBSQS24370038WBSQS24370039WBSQS24370040WBSQS24370041WBSQS23520001WBSQS23520002WBSQS23520003WBSQS23520004WBSQS23510003WBSQS23370019WBSQS23370025WBSQS23510002WBSQS24510069WBSQS24510070WBSQS24510071WBSQS24480060WBSQS24480061WBSQS24370027WBSQS23500001WBSQS23500003WBSQS23500005WBSQS23500006WBSQS23500007WBSQS23500008WBSQS23500004WBSQS24380042WBSQS24380043WBSQS24080001WBSQS24120002WBSQS25040093WBSQS24510066WBSQS24510067WBSQS24510068WBSQS23500009WBSQS24230012WBSQS23210001WBSQS23380026WBSQS23380027WBSQS23380028WBSQS24120003WBSQS24120004WBSQS24120005WBSQS24460048WBSQS24460049WBSQS24460050WBSQS24460051WBSQS24460052WBSQS24460053WBSQS24460054WBSQS24460055WBSQS24460056WBSQS24490062WBSQS23100001WBSQS23310001WBSQS23310002WBSQS24330020WBSQS24330021WBSQS24330022WBSQS24330023WBSQS24110002WBSQS24250013WBSQS24470059WBSQS24210006WBSQS24110006WBSQS24110007WBSQS24110008WBSQS24110009WBSQS24110010WBSQS24110011WBSQS24110019WBSQS24360026WBSQS23460030WBSQS23460031WBSQS24110018WBSQS24470057WBSQS24470058WBSQS23360003WBSQS23360004WBSQS23360005WBSQS23490002WBSQS24120001WBSQS23080001WBSQS23080002WBSQS23080003WBSQS23080004WBSQS23080005WBSQS23080006WBSQS23170001WBSQS23250005WBSQS24210007WBSQS24210008WBSQS23380029WBSQS24510077WBSQS24510078WBSQS23480006WBSQS23480007WBSQS24450047WBSQS24220009WBSQS24220010WBSQS24220011WBSQS23240001WBSQS23240002WBSQS23240003WBSQS23360006WBSQS24520089WBSQS24520090WBSQS23490001WBSQS24090001WBSQS24090002WBSQS24090003WB
What the firm is doing
GE Healthcare issued an URGENT MEDICAL DEVICE notice to its consignees on 03/21/2025 distributed via traceable means. The notice explained the safety issue with the device, potential risk, and requested the following actions be taken: The anesthesia system may continue to be used following the instructions below: Perform the Ventilation Screening Test (specified in Appendix 1) for each affected Carestation system. If the Carestation system passes the Ventilation Screening Test, you can continue to use the device in accordance with the instructions in the User Reference Manual (URM). If the Carestation system fails the Ventilation Screening Test and must be used prior to the system being corrected by GE HealthCare, follow the instructions below: 1. Use the device in accordance with the instructions in the User Reference Manual (URM) with these changes: i. Use only Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) mode to mechanically ventilate a patient. ii. Do not use Volume Control Ventilation (VCV) mode to mechanically ventilate a patient. NOTE: Manual mode of the anesthesia system can be used to provide manual ventilation or allow spontaneous ventilation of the patient. 2. Ensure users are made aware not to use Volume Control Ventilation (VCV) mode on the device until the device has been corrected by GE HealthCare. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions, and retain this document for your record. GE HealthCare will correct all devices that fail the Ventilation Screening Test at no cost. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Notice sent on 04/21/25 with updated ventilation screening test instructions.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1636-2025
- FDA device classification · BSZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5160The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE Medical Systems China Co., Ltd.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination