Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MicroTech Informer Plus Silver Monitors

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MicroTech Informer Plus Silver Monitors see related information
Date Initiated by Firm December 13, 2011
Date Posted April 28, 2012
Recall Status1 Terminated 3 on September 24, 2013
Recall Number Z-1476-2012
Recall Event ID 60698
Product Classification Monitor, bed patient - Product Code KMI
Product 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.
Code Information Serial numbers 071100025 through 111100306
Recalling Firm/
Manufacturer		 Stanley Security Solutions, Inc.
4600 Vine St
Lincoln NE 68503-2823
For Additional Information Contact Gina L. Bennett
407-271-2097
Manufacturer 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
FDA Determined
Cause 2		 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, & email) was included. For question contact Micro-Tech Customer Service at 1-800-206-1045.
Quantity in Commerce 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).
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.
-
-