Recall Z-1285-2022 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
| Date | Apr 25, 2022 |
| Status | Open, Classified |
| Reason | Backup batteries can fail earlier than their estimated life. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction letter dated 04/25/2022 was sent to customers with affected devices. The letter mentions the users can continue to use the ventilator while connected to an AC mains power source that is supported by backup emergency power. The letter provides a series of recommendations for the consignee to follow. The letter also requests that the consignee complete the medical device notification acknowledgement response form and send it back to the firm. |
| Quantity | 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 P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Av Datex-Ohmeda, Inc., Nov 3, 2017 |