Date Initiated by Firm | December 16, 2012 |
Date Posted | February 23, 2013 |
Recall Status1 |
Terminated 3 on February 26, 2013 |
Recall Number | Z-0877-2013 |
Recall Event ID |
63957 |
Product Classification |
Monitor, bed patient - Product Code KMI
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Product | QuietCare-Networked product, Facility Server/model: QC101601;
The QuietCare system is intended to detect and analyze residents' movements. |
Code Information |
All units of this model. |
Recalling Firm/ Manufacturer |
Intel-GE Care Innovations LLC 3721 Douglas Blvd Ste 100 Roseville CA 95661-4243
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For Additional Information Contact | Bonnie Norman 916-356-8438 |
Manufacturer 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. |
FDA Determined Cause 2 | Software design |
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. |
Quantity in Commerce | 19 units |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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