Recall Z-1389-2022 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
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.
| Date | Jul 19, 2022 (initiated Jun 1, 2022) |
| Status | Terminated |
| Reason | There is a potential reversal of the O2 and air cylinder pressure transducer connections. |
| Root cause | Process control |
| Action | The recalling firm issued letters beginning 6/1/2022 via traceable means to the Chief of Anesthesia, Director of Biomedical/Clinical Engineering, and Health Care Administrator/Risk Manager at their consignee locations. The letter was flagged that consignees should ensure all potential users in their facility are made aware of this safety notification and the recommended actions. The letter provided the affected products, safety issue, and actions to be taken. The customer was informed they could continue to use the anesthesia system by following the instructions provided in the letter prio |
| Quantity | 5,372 devices |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Av Datex-Ohmeda, Inc., Nov 3, 2017 |