QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All units of this model.
- 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:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Product Codes/Lot Numbers:
All units of this model.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0877-2013
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. 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. 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.