GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
FDA Device Recall #Z-1626-2025 — Class I — March 21, 2025
Recall Summary
| Recall Number | Z-1626-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | March 21, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems China Co., Ltd. |
| Location | Wuxi, N/A |
| Product Type | Devices |
| Quantity | 27 units |
Product Description
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
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.
Distribution Pattern
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.
Lot / Code Information
GTIN 00195278569677, Serial Numbers: SM624250018WC, SM624250019WC, SM624500025WC, SM624500026WC, SM624500027WC, SM624290020WC, SM624290021WC, SM623470001WC, SM623470002WC, SM623470003WC, SM623470004WC, SM623470005WC, SM623470006WC, SM623470007WC, SM623470008WC, SM623470009WC, SM623470010WC, SM623470011WC, SM623470012WC, SM624240017WC, SM624240013WC, SM624240014WC, SM624240015WC, SM624240016WC, SM624110001WC, SM624330022WC, SM624330023WC.
Other Recalls from GE Medical Systems China Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0913-2026 | Class I | GE Healthcare Carestation anesthesia system, pr... | Nov 14, 2025 |
| Z-0915-2026 | Class I | GE Healthcare Carestation anesthesia system Pow... | Nov 14, 2025 |
| Z-0914-2026 | Class I | GE Healthcare Carestation anesthesia system, pr... | Nov 14, 2025 |
| Z-2029-2025 | Class II | GE Healthcare LOGIQ F R3 Ultrasound System, Mod... | May 16, 2025 |
| Z-2030-2025 | Class II | GE Healthcare Versana Ultrasound Systems, sold ... | May 16, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.