GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient
FDA device recall Z-0854-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter between December 27, 2013 and June 27, 2013, to all affected customers. The letter described the Safety Issues and Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044 or their local Service Representative. For questions regarding this recall call 800-558-7044.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 40,239 (17,182 units US, 23,147 units OUS).
- Distribution
- Nationwide Distribution including DC and PR, except DE, SD, ND, and VT. OUS: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, C
- Date initiated
- 2013-12-27
- Date posted
- 2014-01-28
- Date terminated
- 2017-06-23
- 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 |
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |