GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste

FDA device recall Z-1389-2022 · posted 2022-07-19 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

Action taken

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 prior to use. A Medical Device Notification Acknowledgement Response form was enclosed to acknowledge receipt and understanding of the notice. The consignee was to record their anesthesia system serial number, whether it passed or failed the test, and the date of the test. The response form was supposed to be completed and returned no later than 30 days from receipt.

Root cause

Process control

Status

Terminated

Product code

BSZ

Quantity affected

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,

Date initiated

2022-06-01

Date posted

2022-07-19

Date terminated

2024-10-21

Location

Waukesha, WI

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