The Recall Desk
HighFDA (Devices)·Z-1286-2022·Announced 2022-07-06

Anesthesia device backup batteries may fail prematurely, GE Healthcare recalls

GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting critical backup power systems for anesthesia devices with no reported illnesses or injuries. This meets the rubric criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling field replacement backup battery kits distributed on or after April 1, 2019 that may fail earlier than their estimated lifespan. These batteries are installed in anesthesia devices where they provide backup power for critical operating room equipment.

The affected batteries (part numbers 1009-5682-000-S and 5856787-S) are used in Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View anesthesia systems. Approximately 88,347 batteries were distributed worldwide, including to the United States and more than 50 other countries.

No illnesses or injuries related to battery failures have been reported.

The recalled product

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
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Equipment
Hazard
  • battery-failure
  • power-loss

Distribution

Distributed nationwide across the United States.

Related recalls

Same category