GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss
GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.
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 where the loss of alarm sounds poses a risk of harm to patients, but no injuries or illnesses have been reported, fitting 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 involves 21,799 units distributed worldwide, including 7,635 units in the United States and 14,164 units outside the US.
The recall is due to a potential sound loss issue. When an external display is connected to the monitor using a USB extender cable with an active USB hub, the system may lose sound, including critical alarm sounds, if the external display is powered off and on during normal operation.
Healthcare facilities should check their inventory for affected serial numbers listed in the recall notice. If a unit is affected, the facility should contact GE Healthcare for instructions on corrective action to ensure alarm functionality is restored.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
Distribution
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