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.
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 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
Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- 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
- HighGE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
FDA (Devices) · 2014-02-05
- HighGE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss
FDA (Devices) · 2014-07-30
- HighGE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss
FDA (Devices) · 2014-02-12
- HighGE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue
FDA (Devices) · 2013-09-25