Events

Recall of Device Recall Medrad Veris MR Monitors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad Mr 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
    66996
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-2014
  • Event Initiated Date
    2013-11-21
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124462
  • 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,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    The main board, p/n 301641, installed in some medrad veris mr monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.
  • Action
    The firm, Bayer HealthCare, sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated November 21, 2013 via certified mail to its users/customers. The letter described the product, problem and actions to be taken. The firm stated that, "You may choose to continue to use your Veris units but you MUST be vigilant about this potential issue. Should a shutdown occur, the system can be quickly restarted by pressing the POWER button. If this problem does occur, we ask that you report this immediately to Bayer Customer Support at 1-877-229-3767." The customers were instructed to verify the serial number on your Medrad Veris unit(s). If this problem does occur, report this immediately to Bayer Customer Support at 1-877-229-3767. The customers were also instructed to fill out and fax back the attached form. Bayer Service Representative will then be in touch to schedule an appointment to come and replace your main board, at no cost to you. Bayer also informed their customers that based on the maximum inventory that can be produced by the supplier, they anticipate that this Field Corrective Action will take up to six months. If you have questions, please contact our Customer Support team at 1-877-229-3767.

Device

Device Recall Medrad Veris MR Monitors
  • Model / Serial
    P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: Canada.
  • Product Description
    Medrad Veris MR Monitor units || The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
  • Manufacturer
    Medrad Mr Inc

Manufacturer

Medrad Mr Inc
  • Manufacturer Address
    Medrad Mr Inc, 100 Global View Dr, Warrendale PA 15086-7601
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA