QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Class I - DangerousWhat Should You Do?
- Check if you have this product: US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Intel-GE Care Innovations LLC
- Reason for Recall:
- Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Product Codes/Lot Numbers:
US QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK QuietCare: QCE200403, v.02; QCE200403, v.03
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1375-2013
Related Recalls
It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Intel-GE Care Innovations
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Intel-GE Care Innovations
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.