GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Reported: May 20, 2015 Initiated: May 4, 2015 #Z-1606-2015
Product Description
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Reason for Recall
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
Details
- Recalling Firm
- GE Healthcare
- Units Affected
- 110 (83 units US, 27 units OUS)
- Distribution
- Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).. Recalled by GE Healthcare. Units affected: 110 (83 units US, 27 units OUS).
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1606-2015.
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