[pending] GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Pending LLM rewrite. Source: FDA_DEVICE Z-1625-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
The recalled product
- Product
- GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Category
- Medical Device — Devices
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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