GE CARESCAPE Monitors May Fail to Power On After Battery Replacement
GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.
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: This is a Class II recall involving medical monitors critical to patient care. No illnesses, injuries, or deaths have been reported. The hazard represents a risk-of-harm scenario where patient monitoring equipment could become inoperable, fitting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE Healthcare has issued a recall of CARESCAPE B650 patient monitors and related models (CARESCAPE Canvas 1000, Canvas Smart Display, and certain CARESCAPE B850 models) due to a potential risk of loss of monitoring. The hazard occurs if a mains power loss happens during active patient monitoring following replacement of the CPU timekeeper battery.
If mains power is lost following battery replacement, the affected monitors or displays may not turn on after power is restored. This malfunction could result in a delay in recognizing changes in patient condition until a replacement monitor is connected, potentially affecting clinical response time and patient care.
Approximately 54,800 units are affected worldwide. Specific model numbers and serial numbers are listed in the recall details. GE Healthcare recommends that healthcare facilities verify whether their CARESCAPE devices are affected and contact the manufacturer for guidance on safe battery replacement procedures or device replacement options.
The recalled product
- Product
- CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
- Manufacturer
- GE Healthcare Finland Oy
- Hazard
- monitoring-loss
- device-failure
- power-loss-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00840682143806: a) MBB313: 1) 2095801-001
- Serial Numbers: STF21330010HA
- STF21330023HA
- STF21400190HA
- SNS20303110SA
- SNS20363001SA
- SNS20392015SA
- SS620481053HA
- 2) 2095801-001-01018416
- Serial Numbers: STF22200047HA
- STF22200048HA
- STF22200061HA
- STF22200062HA
- STF22200065HA
- STF22200066HA
- STF22200067HA
- STF22200068HA
- STF22200069HA
- STF22200070HA
- STF22200071HA
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03