GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class I for a medical device used in critical care (anesthesia delivery), and the hazard directly affects a core life-support function (ventilation). Although no injuries or deaths are reported in the source, the Class I designation and the critical safety function involved warrant a Severe classification per the rubric.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling certain GE Healthcare CARESTATION 620 A1 anesthesia delivery systems (Model/REF Number 1012-9620-000). The recalled systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
Approximately 2,253 units of the affected anesthesia systems have been distributed worldwide, including throughout the United States and Puerto Rico, as well as internationally to numerous countries.
Clinicians can achieve effective ventilation using alternative modes on the affected systems: Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation. Facilities with affected systems should review their ventilation procedures and verify that alternative ventilation modes are available for clinical use.
Healthcare providers with questions should contact GE Medical Systems or consult the FDA recall notification at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1624-2025 (Recall Number Z-1624-2025).
The recalled product
- Product
- GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- functional-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00840682103985
- Serial Numbers: SM623390002MA
- SM623390003MA
- SM623020017MA
- SM623480018MA
- SM623480019MA
- SM623480020MA
- SM623480021MA
- SM623110013MA
- SM623060017MA
- SM623060018MA
- SM623060019MA
- SM623060020MA
- SM624440004MA
- SM624440005MA
- SM623320003MA
- SM624050005MA
- SM624050006MA
- SM624130001MA
- SM624200013MA
Distribution
Distributed nationwide across the United States.
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