Reported May 7, 2025 · Ongoing
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
GE Medical Systems China Co., Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · Dev. Zone · Wuxi · N/A
Is this the product you have?
- GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
- Lot codes and dates
- GTIN 00840682103985
- Serial Numbers
2,171 of 2,171 codes
SM623390002MASM623390003MASM623020017MASM623480018MASM623480019MASM623480020MASM623480021MASM623110013MASM623060017MASM623060018MASM623060019MASM623060020MASM624440004MASM624440005MASM623320003MASM624050005MASM624050006MASM624130001MASM624200013MASM623440005MASM623440006MASM624140002MASM624480001MASM624480002MASM624510003MASM623110002MASM624110001MASM624380012MASM623360001MASM624100016MASM625050001MASM625050002MASM625050003MASM623050014MASM623320010MASM623320011MASM623320012MASM623360006MASM623360007MASM624010030MASM624040016MASM624040017MASM624040018MASM623020014MASM623020011MASM623020012MASM623020013MASM624260001MASM623030011MASM623030012MASM623220006MASM624500001MASM623480014MASM623020016MASM623290014MASM623360003MASM623360004MASM624100014MASM623060032MASM623030006MA
- Amount recalled
- 2298 units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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