GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss
GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.
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: The recall involves a medical device with a risk of harm (loss of monitoring parameters) where no injuries or illnesses have been reported, which aligns with the rubric criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling approximately 41,992 CARESCAPE Monitor B850, B650, and B450 patient monitors. The recall covers units distributed in the United States and worldwide.
The recall is due to a defect where the Patient Data Module (PDM) may not start communicating with the monitor when connected to units running software version 2. This failure can result in a partial loss of monitoring, specifically the loss of PDM parameters.
The source text does not specify reported injuries, illnesses, or fatalities associated with this defect. Consumers and healthcare facilities should check their device serial numbers against the recall list and contact GE Healthcare for instructions on corrective action.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
Distributed nationwide across the United States.
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Similar recalls
- HighGE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss
FDA (Devices) · 2014-02-12
- HighGE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms
FDA (Devices) · 2020-07-01
- HighGE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
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- HighGE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues
FDA (Devices) · 2013-09-25
- HighGE Healthcare Recalls CARESCAPE Monitor B650 Patient Monitors
FDA (Devices) · 2013-02-20
- ModerateGE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues
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