FDA Devices Critical Class I Terminated

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.

Reported: July 27, 2022 Initiated: June 1, 2022 #Z-1389-2022

Product Description

Reason for Recall

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

Details

Recalling Firm: GE Healthcare, LLC
Units 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, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
Location: Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by GE Healthcare, LLC. Units affected: 5,372 devices.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 27, 2022. Severity: Critical. Recall number: Z-1389-2022.