ClearanceBrief
Recall Z-1375-2013 ยท IQA System, Environmental Control, Powered

Intel-GE Care Innovations LLC

QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

DateMay 24, 2013 (initiated Apr 4, 2013)
StatusTerminated
ReasonCustomers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Root causeSoftware design
ActionCare Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.
Quantity1722S; 99 Out of US
DistributionUS and Great Britain
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.