Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare Recalled by GE Healthcare Due to The heart rate could be calculated from pacer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare directly.
Affected Products
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Quantity: 110 (83 units US, 27 units OUS)
Why Was This Recalled?
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment
Where Was This Sold?
This product was distributed to 3 states: CO, MI, WI
About GE Healthcare
GE Healthcare has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report