The Recall Desk
HighFDA (Devices)·Z-1285-2022·Announced 2022-07-06

Backup batteries in Avance CS2 anesthesia machines fail prematurely

GE Healthcare is recalling backup batteries in Avance CS2 and CS2 Pro anesthesia machines manufactured after April 1, 2019. Batteries may fail earlier than expected, affecting approximately 6,600 devices worldwide.

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: This is a risk-of-harm product (anesthesia equipment with backup power function) where premature battery failure could compromise patient safety during procedures. No adverse events have been reported in the source material, keeping the score at High rather than Severe.

Plain-English summary

GE Healthcare is recalling backup batteries in Avance CS2 and Avance CS2 Pro anesthesia machines manufactured on or after April 1, 2019. The recalled batteries are in approximately 6,612 units distributed worldwide.

The backup batteries may fail earlier than their expected service life. Battery failure could affect the backup power system's ability to maintain anesthesia device function during primary power loss.

The recall affects Avance CS2 and CS2 Pro machines distributed globally. Affected facilities should contact GE Healthcare with their device model numbers and serial numbers to verify whether their equipment is involved and to obtain information about corrective actions.

The recalled product

Product
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
6,612

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number: 1009-9050-000
  • UDI/DI: 00840682102322
  • Serial Numbers: APKB00323
  • APKB00324
  • APKB00325
  • APKB00326
  • APKB00327
  • APKB00328
  • APKZ01002
  • APKB00236
  • APKB00237
  • APKB00238
  • APKB00239
  • APKB00240
  • APKA00595
  • APKA00596
  • APKA01159
  • APKB00159
  • APKB00241
  • APKB00242

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · battery failure

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