FDAFDA · Food and drugs·Recall number Z-0877-2013
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Published March 6, 2013 · Recall initiated: December 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intel-GE Care Innovations LLC
- Distributor
- Nationwide Distribution.
- Lot
- All units of this model.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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