GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use
FDA device recall Z-2256-2013 · posted 2013-09-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
- Action taken
- GE Healthcare sent an Important Product Information letter dated July 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will provide a software and hardware correction at no charge once it is available. We will contact you to arrange for this correction. If you have any questions regarding this notification, please contact Technical Support (1-800- 558-7044) or your local Service Representative
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 9466 (3261 US, 6205 OUS)
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of : AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC
- Date initiated
- 2012-07-12
- Date posted
- 2013-09-19
- Date terminated
- 2014-04-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE MONITOR B650 (K102239) | GE Healthcare Finland Oy | 2010-10-18 |