Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Li

FDA device recall Z-1476-2012 · posted 2012-04-28 · Terminated

Recall details

Recalling firm

Stanley Security Solutions, Inc.

Reason for recall

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 taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

KMI

Quantity affected

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).

Date initiated

2011-12-13

Date posted

2012-04-28

Date terminated

2013-09-24

Location

Lincoln, NE