GE Healthcare Recalls CARESCAPE Bx50 Monitors for Pacemaker Detection Defect
GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect could result in 'irreversible changes in the patient's condition and delayed or missed life sustaining patient treatment,' which aligns with the rubric criterion for 'significant injury' reports or risk of serious harm.
Plain-English summary
GE Healthcare is recalling 110 units of CARESCAPE Monitor B850, B650, and B450 (Bx50) devices. The recall affects 83 units in the United States and 27 units outside the US, distributed to Colorado, Michigan, Wisconsin, the Netherlands, Finland, and Belgium.
The recall is due to a defect where the heart rate could be calculated from pacemaker pulses without the monitor indicating that pacemaker detection is OFF. In certain combinations of Bx50 monitors, a PDM, and CIC/CSCS, the monitor may not display the 'Pacer Off' message and may not alarm for asystole. This failure could result in undetected asystole, leading to irreversible changes in the patient's condition and delayed or missed life-sustaining treatment.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact GE Healthcare for instructions on corrective action.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Patient Monitor
Distribution
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