GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, 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 is an FDA Class I recall, which per the rubric requires a severity score of at least 4 (Severe). The device failure affects ventilation delivery in an anesthesia system, posing a risk of serious harm if used in VCV mode.
Plain-English summary
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation when operated in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can still be achieved using Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG) modes, or by switching to manual ventilation.
The affected product includes the GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012, with GTIN 00195278569684 and Serial Number SM724370002WC. The manufacturer is GE Medical Systems China Co., Ltd.
The recall applies to a single unit and covers worldwide distribution, including US nationwide distribution and numerous countries across multiple continents.
Healthcare facilities and users should immediately stop using the affected anesthesia systems in VCV mode and switch to PCV, PCV-VG, or manual ventilation. Contact GE Healthcare for further instructions regarding the recall.
The recalled product
- Product
- GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- 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 (2)
- GTIN 00195278569684
- Serial Numbers: SM724370002WC
Distribution
Distributed nationwide across the United States.
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