FDA Recall Terminated

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 of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.

Recall: Z-1476-2012 · Initiated December 13, 2011

Recall

Recall Number
Z-1476-2012
Event Number
60698
Firm
Stanley Security Solutions, Inc.
FEI Number
1929691
Product Code
KMI
Status
Terminated
Root Cause
Component design/selection
Initiated
December 13, 2011
Posted
April 28, 2012
Terminated
September 24, 2013
Address
4600 Vine St, Lincoln, NE, 68503-2823

Description

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 of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.

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

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, & email) was included. For question contact Micro-Tech Customer Service at 1-800-206-1045.

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).

Quantity

824 units