Events

Recall of Device Recall Tabs Professional Monitor, Model 25023

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
    55186
  • Event Risk Class
    Class 2
  • Event Number
    Z-1945-2010
  • Event Initiated Date
    2010-03-26
  • Event Date Posted
    2010-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90248
  • 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
    Bed-Patient Monitor - Product Code KMI
  • Reason
    Product might not indicate low battery alarms or exit alarms when powered by a dc power supply.
  • Action
    The firm made phone calls beginning 3/26/10 to customers who purchased the 12-volt power supply informing them of the recall and instructing them to determine the number of units that will need to be returned for replacement. Important Safety Notice letters dated 3/25/10 were issued via regular mail on 3/26/10 and also providing the reason for the recall, instructions, and customer service contact information to arrange for return of the units.

Device

Device Recall Tabs Professional Monitor, Model 25023

Manufacturer

Stanley Security Solutions, Inc.
  • Manufacturer Address
    Stanley Security Solutions, Inc., 1550 N 20th Cir, Lincoln NE 68503
  • Manufacturer Parent Company (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA