PlainRecalls
FDA Devices Moderate Class II Ongoing

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

Reported: July 6, 2022 Initiated: April 25, 2022 #Z-1285-2022

Product Description

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

Reason for Recall

Backup batteries can fail earlier than their estimated life.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
6,612 devices
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao PDR, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Nepal, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019. Recalled by GE Healthcare, LLC. Units affected: 6,612 devices.
Why was this product recalled?
Backup batteries can fail earlier than their estimated life.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1285-2022.