GE Healthcare CARESTATION anesthesia systems may not ventilate effectively
Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.
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 (anesthesia system) affecting patient ventilation, a critical function. Class I recalls are inherently at least Severe (score 4) per the rubric, as they carry significant risk of serious harm or death even without reported adverse events.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling certain CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems. These systems may not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode.
Approximately 815 units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as internationally to numerous countries.
Effective ventilation can be achieved by using Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or manual ventilation. Users should contact GE Healthcare for further guidance on device operation and any necessary corrective actions.
No injuries or illnesses are reported in the source material related to this issue.
The recalled product
- Product
- GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- ineffective-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 (20)
- GTIN 00840682124560
- Serial Numbers: SM723010002WB
- SM723010003WB
- SM723010004WB
- SM723010005WB
- SM723010001WB
- SM724010002WB
- SM724010003WB
- SM724010004WB
- SM724010005WB
- SM724010006WB
- SM724010007WB
- SM724010008WB
- SM724010009WB
- SM724010010WB
- SM724010011WB
- SM724010012WB
- SM724010013WB
- SM724010014WB
- SM724480168WB
Distribution
Distributed nationwide across the United States.
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