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.
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 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
Distribution
Distributed nationwide across the United States.
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