FDA-Device2022-07-06Class II
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
GE Healthcare, LLC
Hazard
Backup batteries can fail earlier than their estimated life.
Sold states
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.
Affected count
6,612 devices
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1285-2022Don't want to check this manually?
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