Events

Recall of Device Recall Sensatec ST500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RF Technologies, 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
    25279
  • Event Risk Class
    Class 2
  • Event Number
    Z-0446-03
  • Event Initiated Date
    2002-12-16
  • Event Date Posted
    2003-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25521
  • 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
    In some cases the unit appears to be monitoring the patient, when in fact the alarm is silenced.

Device

Device Recall Sensatec ST500

Manufacturer

RF Technologies, Inc.
  • Manufacturer Address
    RF Technologies, Inc., 3125 N. 126th Street, Brookfield WI 53005
  • Source
    USFDA