Recall Z-2085-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
| Date | Jul 21, 2014 (initiated Jun 13, 2014) |
| Status | Terminated |
| Reason | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur. |
| Root cause | Software design |
| Action | Consignees were sent on 6/13/2014 a GE Healthcare "Urgent Medical Device Correction" letter #36103, 36104 and 36105 dated June 6, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information. Consignees were advised to contact Technical Support at 800-558-7044 in regard to questions on this recall. |
| Quantity | 41,992 (20,509 US; 21,483 OUS) |
| Distribution | Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAN |
| 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 |
| K131223 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Aug 28, 2013 |
| K131414 | CARESCAPE MONITOR B850 GE Healthcare Finland Oy, Aug 28, 2013 |
| K132523 | MYOPERFUSION Toshibamedical Systems Corporation, Dec 12, 2013 |
| K192239 | WavelinQ Plus EndoAVF System C.R. Bard, Inc., Oct 17, 2019 |