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.
- Affected units
- 27
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
Part of a larger recall action
This product is one of 15 recalled by GE Medical Systems China Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · GE Medical Systems China Co., Ltd.
See all →- HighGE MAC 5 ECG systems may link data to the wrong patient
FDA (Devices) · 2026-06-10
- CriticalAnesthesia power management boards recalled over potential unexpected system shutdown
FDA (Devices) · 2025-12-24
- CriticalCarestation 750 anesthesia systems recalled over potential unexpected shutdown
FDA (Devices) · 2025-12-24
- CriticalAnesthesia systems recalled over potential unexpected shutdown on mains power loss
FDA (Devices) · 2025-12-24
- HighGE Healthcare Versana Ultrasound Systems display incorrect fetal weight data
FDA (Devices) · 2025-07-02
Same hazard · ventilation defect
See all →- HighGE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall
FDA (Devices) · 2022-02-16
- HighGE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
FDA (Devices) · 2022-02-16
- HighGE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect
FDA (Devices) · 2022-02-16