Recall Z-1476-2012 ยท KMI Monitor, Bed Patient
Stanley Security Solutions, Inc.
Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width o
| Date | Apr 28, 2012 (initiated Dec 13, 2011) |
| Status | Terminated |
| Reason | Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system |
| Root cause | Component design/selection |
| Action | Stanley Healthcare Solutions, Inc. contacted affected customers via phone and email on December 13, 2011. A follow-up certified letter was sent on December 14, 2011. Customers were additionally sent and "Important Recall Notice letter on December 16, 2011 after errors in the original letters were detected. The letter identified the affected product, problem, actions to be taken, and included a reply form for the customer to complete and return. The recalling firm requested their customers to stop using the monitor and contact them for return of the unit. Contact information (phone, fax, & |
| Quantity | 824 units |
| Distribution | Worldwide Distribution - USA Nationwide including the states of CT, FL, KY, MN, NC, NE, NH, NJ, NY, PA, TX and the country of Canada (5 units). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.