CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor int
FDA device recall Z-1567-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
- Action taken
- GE Healthcare sent "Important Product Information" letter dated 12 July 2012 to all affected customers. The letter described the Subject (issues) , Instructions, Affected Product Details, Product Correction and actions to be taken. For questions contact Technical Support 1-800-558-7044 or your local Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 12,779
- Distribution
- Worldwide Distribution - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH,
- Date initiated
- 2012-07-20
- Date posted
- 2013-06-21
- Date terminated
- 2014-06-30
- 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 |