Recall Z-0202-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies, Inc.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. |
| Root cause | Software Design Change |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any que |
| Quantity | 1,196 (1,176 US; 20 OUS) |
| Distribution | Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |