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.
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 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…
- 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 · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- 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 Recalls CARESCAPE Monitor B650 Due to Sound Loss
FDA (Devices) · 2014-07-30
- ModerateGE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues
FDA (Devices) · 2013-07-03
- ModerateGE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues
FDA (Devices) · 2018-10-17
- HighGE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss
FDA (Devices) · 2014-02-12