Product Wiki · Recalls · U.S. FDA — Device Enforcement

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

U.S. FDA — Device Enforcement · United States · 2012-12-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0877-2013
Date of alert
2012-12-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intel-GE Care Innovations LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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