CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended fo
FDA device recall Z-2275-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 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,
- Date initiated
- 2010-07-16
- Date posted
- 2010-08-25
- Date terminated
- 2013-09-18
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |