QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze res
FDA device recall Z-0877-2013 · posted 2013-02-23 · Terminated
Recall details
- Recalling firm
- Intel-GE Care Innovations LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KMI
- Quantity affected
- 19 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-12-16
- Date posted
- 2013-02-23
- Date terminated
- 2013-02-26
- Location
- Roseville, CA
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