GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure
Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.
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 medical device recall. A defect in an anesthesia system's primary ventilation mode creates significant potential for patient harm in a critical-care setting, even though no hospitalizations or adverse events are reported in the source text.
Plain-English summary
GE Medical Systems China Co., Ltd. is recalling certain CARESTATION anesthesia delivery systems, including models 620, 650, 650c, 750, and 750c with the specific reference number 1012-9620-002, due to a ventilation delivery defect.
The affected systems will not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. However, effective ventilation can be achieved using alternative modes: Pressure Control Ventilation (PCV), Pressure Control Ventilation Volume Guarantee (PCV-VG), or Manual ventilation.
Approximately 1,483 units have been distributed worldwide, including throughout the United States and Puerto Rico. Healthcare facilities and medical professionals using these systems should use PCV, PCV-VG, or Manual ventilation modes in place of VCV mode until the systems are serviced.
Healthcare providers with affected units should contact GE Medical Systems for guidance on corrective action.
The recalled product
- Product
- GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. 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 (20)
- GTIN 00840682124546
- Serial Numbers: SM623510024WB
- SM623510028WB
- SM623510029WB
- SM623510030WB
- SM623510031WB
- SM623510032WB
- SM623510025WB
- SM623510026WB
- SM623510027WB
- SM624390041WB
- SM624390042WB
- SM623510033WB
- SM623510034WB
- SM624220006WB
- SM624220008WB
- SM623160001WB
- SM623160002WB
- SM624120009WB
- SM624120010WB
Distribution
Distributed nationwide across the United States.
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