FDAFDA · Food and drugs·Recall number Z-1375-2013
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Published June 5, 2013 · Recall initiated: April 4, 2013
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
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Intel-GE Care Innovations LLC
- Distributor
- US and Great Britain
- Lot
- US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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