GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall
GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
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: The FDA classified this as a Class I recall. Although no injuries or illnesses are reported in the source text, the defect affects critical ventilation functionality in a medical device used during anesthesia delivery. Per the rubric, FDA Class I recalls with medical device context warrant a Severe (4) rating when the hazard directly impacts patient safety during active clinical use.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling 27 units of the GE Healthcare Carestation 620 SE anesthesia system (Model/REF Number 1012-9620-012) due to a defect in ventilation functionality.
The affected systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. However, effective ventilation can be achieved using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation.
The affected units have been distributed worldwide, including throughout the United States and Puerto Rico. Customers using affected systems should verify that they are operating in PCV, PCV-VG, or Manual ventilation modes, or contact the manufacturer for further guidance.
For a complete list of affected serial numbers and additional information, contact GE Medical Systems China Co., Ltd. or refer to FDA recall number Z-1626-2025.
The recalled product
- Product
- GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-defect
- medical-device-malfunction
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 00195278569677
- Serial Numbers: SM624250018WC
- SM624250019WC
- SM624500025WC
- SM624500026WC
- SM624500027WC
- SM624290020WC
- SM624290021WC
- SM623470001WC
- SM623470002WC
- SM623470003WC
- SM623470004WC
- SM623470005WC
- SM623470006WC
- SM623470007WC
- SM623470008WC
- SM623470009WC
- SM623470010WC
- SM623470011WC
- SM623470012WC
Distribution
Distributed nationwide across the United States.
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