Cl ll QuietCare-Networked product Facility server

Company:Intel-GE Care Innovations LLC.
Date of Enforcement Report 3/6/2013
Class ll:

PRODUCT

QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements.
Recall Number Z-0877-2013

REASON
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.

RECALLING FIRM/MANUFACTURER
Intel-GE Care Innovations LLC, Rosevill, CA on 12/15/2012. Voluntary: Firm Initiated recall has been terminated

VOLUME OF PRODUCT IN COMMERCE
19 units

DISTRIBUTION
Nationwide

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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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