Patient monitors recalled over batteries that can lose backup power
GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
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: Scored 3 under the risk-of-harm criterion: loss of patient monitoring can delay recognition of a deteriorating patient, and no injuries are reported.
Plain-English summary
The Carescape B450 physiological patient monitor, model 5805686, shipped with potentially affected batteries or with affected batteries installed as a spare part, is being recalled. The record notes it was updated on 19 March 2026 to include further Carescape B450 configurations.
The firm describes a potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose the capability to hold charge and provide backup power. If this occurs, it will cause loss of patient monitoring and potentially delay recognising patient status changes requiring treatment.
The recall covers 3,271 units carrying UDI-DI 00840682146135, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
Sites operating an affected monitor should follow GE Healthcare's instructions.
The recalled product
- Product
- Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE M
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Patient monitor
- Hazard
- battery-failure
- loss-of-monitoring
- backup-power
Distribution
Distributed nationwide across the United States.
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