Recall Z-1375-2013— Intel-GE Care Innovations LLC
Class II · Terminated
Class II FDA medical device recall by Intel-GE Care Innovations LLC, initiated 2013-04-04, terminated 2013-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.. Reason: Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product..
- Recalling firm
- Intel-GE Care Innovations LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-04
- Terminated
- 2013-06-04
- Firm location
- Roseville, CA, United States
Product description
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Reason for recall
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.