GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-1286-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: April 25, 2022
Date Posted: July 6, 2022
Recall Number: Z-1286-2022
Event ID: 90137
Reason for Recall:

Backup batteries can fail earlier than their estimated life.

Status: Ongoing
Product Quantity: 88,347 batteries
Code Information:

Field Replacement Units (FRU) Battery kits - PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) or PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR), that may have been installed by the customer into any of the following anesthesia systems: o Avance 1009-9002-000 o Aespire View 1009-9212-000 o Avance CS2 and Avance CS2 Pro 1009-9050-000

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated