Recall Z-2492-2012 ยท KMI Monitor, Bed Patient
Stanley Security Solutions, Inc.
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
| Date | Sep 28, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| Reason | The monitor may fail to sound an alarm |
| Root cause | Device Design |
| Action | Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no |
| Quantity | 12,111 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.