CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

Field replacement back up batteries distributed on or after recalled

GE Healthcare is recalling Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, distributed nationwide in the US. The recall was initiated on 25 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesField 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

Quantity recalled88,347 batteries

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1286-2022
FDA event ID: 90137
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 25 Apr 2022
FDA classified: 24 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Apr 2022	Recall initiated by company
24 Jun 2022	Classified by FDA	+60 days
6 Jul 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Backup batteries can fail earlier than their estimated life.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Backup batteries can fail earlier than their estimated life.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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