GE Healthcare Ventilators Recalled for Insufficient Battery Backup Power
GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Although no reported illnesses or injuries are mentioned in the recall notice, the hazard—insufficient battery backup in life-support ventilators—presents significant risk of serious patient harm from unexpected equipment failure.
Plain-English summary
GE Healthcare, LLC is recalling backup batteries in CARESCAPE R860, ENGSTRÖM, ENGSTRÖM Carestation, and ENGSTRÖM PRO ventilators. A total of 34,940 units are affected. These ventilators have been distributed worldwide, including throughout the United States and numerous international locations.
The backup batteries in the recalled ventilators have insufficient power capacity. When ventilators are not connected to AC mains power, the batteries may fail to provide adequate power, leading to premature ventilator shutdown. Patients requiring continuous mechanical ventilation depend on reliable backup power to maintain life-sustaining respiratory support.
The FDA classified this as a Class I recall—the most serious recall category—because of the significant risk of serious adverse outcomes from unexpected ventilator failure. Healthcare facilities using these ventilators should verify their equipment against the serial numbers listed in the recall notice and contact GE Healthcare, LLC for instructions on remediation or replacement.
The recalled product
- Product
- Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Ventilators
- Affected units
- 34,940
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)
- a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX
- UDI/DI Number:00840682102346
- Serial Numbers: CBRZ06959
- CBRZ80171
- CBRZ80257
- CBRZ40111
- CBRZ85239
- CBRZ05811
- CBRZ05833
- CBRZ05850
- CBRZ05852
- CBRZ05857
- CBRA01434
- CBRA01435
- CBRA01436
- CBRZ80137
- CBRZ80153
- CBRZ80197
- CBRZ84891
- CBRA01744
Distribution
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
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