GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahos
FDA device recall Z-2114-2014 · posted 2014-07-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
- Action taken
- GE Healthcare "Urgent Medical Device Correction" letter #36102 dated July 7, 2014 to affected customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions they can contact Technical Support at 1-800-558-7044 or your local Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 21,799 (7,635 units US, 14,164 units OUS)
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN
- Date initiated
- 2014-07-07
- Date posted
- 2014-07-24
- Date terminated
- 2016-09-07
- 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 |