Recall Z-1606-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2015-05-04, terminated 2015-09-15. It names 5 FDA 510(k) clearances: K132533, K131223, K131414 and 2 more. Product: GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).. Reason: 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.
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-04
- Terminated
- 2015-09-15
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K132533 — CARESCAPE MONITOR B450
- K131223 — CARESCAPE MONITOR B650
- K131414 — CARESCAPE MONITOR B850
- K102239 — CARESCAPE MONITOR B650
- K092027 — CARESCAPE MONITOR B850
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.