Agency classClass IIOur severity:High FDA (Devices)·Z-0454-2026·Announced 2025-11-19

CARESCAPE ONE monitors recalled over batteries that fail to hold charge

GE Healthcare is recalling 5,935 CARESCAPE ONE patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 ONE physiological patient monitor, model 2087075-300, 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 to add the CARESCAPE ONE MBZ101 configuration.

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 5,935 units carrying UDI-DI 00195278288639, 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 ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
Manufacturer: GE Healthcare Finland Oy
Category: Medical Device — Patient monitor
Hazard: battery-failure
loss-of-monitoring
backup-power
Affected units: 5,935

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare Finland Oy 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 5 products in this recall →

Same manufacturer · GE Healthcare Finland Oy

See all →

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Same hazard · battery failure