GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues
GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.
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 potential issues that could pose a risk of harm, but the source explicitly states that no injuries or illnesses have been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling the CARESCAPE Monitor B650, a multi-parameter patient monitor used in professional healthcare facilities. The recall is being conducted because the manufacturer recently became aware of a number of potential issues associated with the device.
The affected units are intended for monitoring and recording various physiological parameters for adult, pediatric, and neonatal patients. The recall covers 9,466 units, with 3,261 units distributed in the United States and 6,205 units distributed outside the US.
No injuries or illnesses have been reported in connection with this recall. Healthcare facilities should contact GE Healthcare for instructions on how to address the potential issues with the affected monitors.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric,
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
Distribution
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