Recall Z-1703-2012 ยท IQA System, Environmental Control, Powered
Intel-GE Care Innovations LLC
Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategic
| Date | Jun 5, 2012 (initiated Aug 1, 2011) |
| Status | Terminated |
| Reason | On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a |
| Root cause | Employee error |
| Action | Intel-GE Care Innovations sent an "URGENT FIELD NOTIFICATION" e-mail dated August 12, 2011 to all affected customers. The notification identifies the product and problem. No action is required by the customers. Contact Customer Service at (866) 772-8243 for questions regarding this notice. |
| Quantity | 61 units were identified as affected |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of Arizona, California, Connecticut, Idaho, Illinois, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.