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Recall Observatory FDA recall evidence

Device product

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

Z-0877-2013

December 16, 2012

Class II

Product summary

Firm
Intel-GE Care Innovations LLC
Event
Event 63957
Status
Terminated
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-0877-2013

Official wording

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.

Code information: All units of this model.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly