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Terminated

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

FDA Recall Z-0877-2013 · Posted 2013-02-23

Recalling FirmIntel-GE Care Innovations LLC
Recall StatusTerminated
Product CodeKMI
Date Initiated2012-12-16
Date Terminated2013-02-26
Product Quantity19 units

Reason for Recall

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.

Firm Action

Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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