| Date Initiated by Firm | April 04, 2013 |
|---|
| Date Posted | May 24, 2013 |
|---|
| Recall Status1 |
Terminated 3 on June 04, 2013 |
| Recall Number | Z-1374-2013 |
|---|
| Recall Event ID |
65031 |
| Product Classification |
System, environmental control, powered - Product Code IQA
|
| Product | QuietCare-Networked.
Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. |
|---|
| Code Information |
QuietCare-Networked: Facility Server QC101601 |
Recalling Firm/
Manufacturer |
Intel-GE Care Innovations LLC
3721 Douglas Blvd Ste 100
Roseville CA 95661-4243
|
| For Additional Information Contact | Bonnie Norman
916-356-8438 |
|---|
Manufacturer Reason
for Recall | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue. |
|---|
| Quantity in Commerce | 46 |
|---|
| Distribution | US and Great Britain |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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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