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Terminated

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

FDA Recall Z-1375-2013 · Posted 2013-05-24

Recall StatusTerminated
Product CodeIQA
Date Initiated2013-04-04
Date Terminated2013-06-04
Product Quantity1722S; 99 Out of US

Reason for Recall

Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.

Firm Action

Care 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.

Root Cause

Software design

Distribution Pattern

US and Great Britain

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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