Recall Z-0927-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmi
| Date | Feb 4, 2014 (initiated Dec 20, 2013) |
| Status | Terminated |
| Reason | There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio |
| Root cause | Component change control |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated December 20, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter addressed the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Call Technical Support at 1-800-558-7044 or your local Service Representative). |
| Quantity | 12, 945 units (6,239 US, 6,706 OUS) |
| Distribution | Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, GUAM, India, INDONESIA, Iraq, Ireland, |
| 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 |