Recall Z-1606-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
| Date | May 12, 2015 (initiated May 4, 2015) |
| Status | Terminated |
| 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 patients condition and delayed or missed life sustaining patient treatment |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 110 (83 units US, 27 units OUS) |
| Distribution | Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092027 | CARESCAPE MONITOR B850 Ge Medical Systems Information Technologies, Aug 28, 2009 |
| K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Oct 18, 2010 |
| K131223 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Aug 28, 2013 |
| K131414 | CARESCAPE MONITOR B850 GE Healthcare Finland Oy, Aug 28, 2013 |
| K132533 | CARESCAPE MONITOR B450 GE Healthcare Finland Oy, Dec 4, 2013 |