Home / Recalls / Medical Devices
Intel-GE Care Innovations LLC recalls QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyz
Recalled March 6, 2013 · FDA recall Z-0877-2013 · Intel-GE Care Innovations
Hazard
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. · FDA Class II
Units
19 units
Sold at
Nationwide Distribution.
Description
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.
Product
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Manufacturer(s)
Intel-GE Care Innovations LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →