Cl ll QuietCare-Networked

Company: Intel-GE Care Innovations LLC .
Date of Enforcement Report: 5/29/2013
Class ll:

PRODUCT

QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Recall Number Z-1374-2013 and Z-1375-2013

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

RECALLING FIRM/MANUFACTURER
Intel-GE Care Innovations LLC., Roseville, CA on 4/4/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
46 devices for recall Z-1374-2013
1722S; 99 Out of US for recall Z-1375-2013

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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