Class 1 Device Recall GE Healthcare CARESTATION

• Date Initiated by Firm: March 21, 2025
• Date Posted: April 29, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1637-2025
• Recall Event ID: 96634
• 510(K)Number: K213867
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
• Code Information: GTIN 00840682146425, Serial Numbers: SQT23330001WA, SQT23080006WA, SQT23080007WA, SQT23080008WA, SQT23080009WA, SQT23080010WA, SQT23080011WA, SQT24440011WA, SQT23150001WA, SQT23070001WA, SQT23070002WA, SQT24430006WA, SQT23200001WA, SQT23200002WA, SQT23200003WA, SQT23200004WA, SQT23200005WA, SQT24290003WA, SQT24510015WA, SQT24520016WA, SQT23360008WA, SQT23360002WA, SQT23360003WA, SQT23360004WA, SQT23360005WA, SQT23360006WA, SQT23360007WA, SQT23170001WA, SQT24430007WA, SQT24430008WA, SQT24430009WA, SQT24430010WA, SQT23190004WA, SQT24410005WA, SQT23050001WA, SQT23050002WA, SQT23050003WA, SQT23050004WA, SQT23060001WA, SQT23060002WA, SQT23060003WA, SQT23300002WA, SQT24230002WA, SQT24440012WA, SQT24440013WA, SQT24440014WA, SQT23400001WA, SQT23400002WA, SQT24022000WA, SQT23480001WA, SQT23370002WA, SQT23370007WA, SQT23370004WA, SQT23370006WA, SQT23370005WA, SQT23370001WA, SQT23370003WA, SQT23370008WA, SQT23370009WA, SQT23370010WA, SQT23370011WA, SQT23460001WA, SQT24160001WA, SQT23350001WA, SQT23420001WA, SQT23420002WA, SQT23190001WA, SQT23190002WA, SQT23190003WA, SQT23190005WA, SQT23190006WA, SQT23190007WA, SQT23190008WA, SQT23190009WA.
• Recalling Firm/ Manufacturer: GE Medical Systems China Co., Ltd.; Dev. Zone; National Hi-Tech; No. 19 Changjiang Road; Xin; Wuxi China
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 74 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BSZ