Recall Z-2114-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
| Date | Jul 24, 2014 (initiated Jul 7, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Oct 18, 2010 |