GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly
GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to 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: This is an FDA Class I recall of a medical device used in anesthesia delivery. Class I recalls by definition carry the potential for serious adverse health consequences, and a ventilation failure in an anesthesia system poses significant risk of harm to patients even though no illnesses or injuries are reported in the source text.
Plain-English summary
GE Healthcare is recalling certain CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems worldwide, including in the United States and Puerto Rico. These systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
The affected anesthesia systems are GE Medical Systems China Co., Ltd. Model/REF Number 1012-9755-002 units with serial numbers SQT23170001WB, SQT23430001WB, SQT23230001WB, SQT24110001WB, and SQT24020001WB (GTIN 00840682146463). Five units have been distributed worldwide.
In affected systems, effective ventilation can still be achieved using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or Manual ventilation. Healthcare facilities using these anesthesia systems should verify their ventilation mode settings and contact GE Healthcare for repair or replacement.
The recalled product
- Product
- GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- inadequate-anesthesia-delivery
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 (6)
- GTIN 00840682146463
- Serial Numbers: SQT23170001WB
- SQT23430001WB
- SQT23230001WB
- SQT24110001WB
- SQT24020001WB
Distribution
Distributed nationwide across the United States.
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