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.
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: 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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