GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Aisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - GTIN: 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare, LLC
- Reason for Recall:
- There is a potential reversal of the O2 and air cylinder pressure transducer connections.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Product Codes/Lot Numbers:
Aisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - GTIN: 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1389-2022
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