FDA-Device2013-03-06Class II
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Intel-GE Care Innovations LLC
Hazard
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.
Sold states
Nationwide Distribution.
Affected count
19 units
Manufactured in
3721 Douglas Blvd Ste 100, N/A, Roseville, CA, United States
Products
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2013Don't want to check this manually?
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