Recall Z-2275-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
| Date | Aug 25, 2010 (initiated Jul 16, 2010) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off. 3. The CARESCAPE Monitor B850 will not use user entered hemo |
| Root cause | Software design |
| Action | Consignees were sent on 7/16/10, a GE "Urgent Medical Device Correction" letter dated July 12, 2010. The letter was addressed to Healthcare Administrator/Risk Manger, Chief of Nursing, Director of Biomedical Engineering. They stated the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. If you have any questions, please contact Technical Support at 1-800-558-7044. |
| Quantity | 875 |
| Distribution | CA, CO, FL, GA, KY, LA, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TX VA, and WI, Foreign: UNITED KINGDOM, TURKEY, SWITZERLAND, SPAIN , SLOVENIA, SINGAPORE, SAUDI ARABIA, PORTUGAL NETHERLAND, ITALY, GERMANY, FRANCE,FINLAND, DENMARK, CZECH REPUBLIC, BELGIUM, AUSTRIA, and AUSTRALIA. |
| 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 |