Events

Recall of Device Recall Tabs Professional Voice Monitor, Model 25223

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanley Security Solutions, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61796
  • Event Risk Class
    Class 2
  • Event Number
    Z-2492-2012
  • Event Initiated Date
    2012-05-04
  • Event Date Posted
    2012-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109112
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, bed patient - Product Code KMI
  • Reason
    The monitor may fail to sound an alarm.
  • 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 later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.

Device

Device Recall Tabs Professional Voice Monitor, Model 25223
  • Model / Serial
    Serial numbers 236348 thru 347416
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
  • Product Description
    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.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Manufacturer Address
    Stanley Security Solutions, Inc., 4600 Vine St, Lincoln NE 68503-2823
  • Manufacturer Parent Company (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA