Z-1286-2022Class II

Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro...

Name: Z-1286-2022 Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro...
Creator: GE Healthcare, LLC
Published: 2022-04-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-04-25 / Open, Classified

FDA source

GE Healthcare, LLC began a recall of Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices on 2022-04-25. FDA classified it as Class II and gives the reason as "Backup batteries can fail earlier than their estimated life". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1286-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-25
Posted: 2022-06-24
Recalling firm: GE Healthcare
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
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Backup batteries can fail earlier than their estimated life.
FDA 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 in commerce: 88,347 batteries
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1286-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1285-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-24
Z-1286-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-24

Product code BSZ

K172045Class IIAestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc. / cleared 2017-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)