FDA recall Z-1286-2022

Product

Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices

Reason for recall

Backup batteries can fail earlier than their estimated life.

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.

Key facts

Status

Ongoing

Initiation date

2022-04-25

Report date

2022-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2022