Recall Z-0877-2013— Intel-GE Care Innovations LLC
Class II · Terminated
Class II FDA medical device recall by Intel-GE Care Innovations LLC, initiated 2012-12-16, terminated 2013-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.. 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..
- Recalling firm
- Intel-GE Care Innovations LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-16
- Terminated
- 2013-02-26
- Firm location
- Roseville, CA, United States
Product description
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.