QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intende...
FDA Recall #Z-0877-2013 — Class II — December 16, 2012
Product Description
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Reason for Recall
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.
Recalling Firm
Intel-GE Care Innovations LLC — Roseville, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19 units
Distribution
Nationwide Distribution.
Code Information
All units of this model.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated