Recall Z-0877-2013 ยท KMI Monitor, Bed Patient
Intel-GE Care Innovations LLC
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
| Date | Feb 23, 2013 (initiated Dec 16, 2012) |
| Status | Terminated |
| Reason | Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered. |
| Root cause | Software design |
| Action | Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice. |
| Quantity | 19 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.