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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 5,372 Aisys CS2 and Avance CS2/CS2 Pro anesthesia systems distributed worldwide due to a potential reversal of the oxygen and air cylinder pressure transducer connections. The affected devices include specific serial numbers for each model type, with the Aisys CS2 identified by GTIN 00840682102292 and the Avance CS2/CS2 Pro identified by GTIN 00840682102322.
The recall notice does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Reason for recall: There is a potential reversal of the O2 and air cylinder pressure transducer connections. Distribution: Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philip Quantity: 5,372 devices Lot/code info: 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,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.