Events

Recall of Accusorb MRI Products

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MWT Materials, 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
    72202
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-2016
  • Event Initiated Date
    2014-10-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140187
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    When not used correctly, accusorb mri products may overheat and lead to patient injury.
  • Action
    MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to info@MWT-Materials.com.

Device

Accusorb MRI Products
  • Model / Serial
    All
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of NY and MA.
  • Product Description
    Accusorb MRI || MAC7001 || Part Number: MRI-01 || MRI-Large Blanket Various Sizes || Product Usage: || Radio frequency shielding blankets and body-part covers for the MRI environment.
  • Manufacturer
    MWT Materials, Inc.

Manufacturer

MWT Materials, Inc.
  • Manufacturer Address
    MWT Materials, Inc., 90 Dayton Ave Ste 6E Building 21, Passaic NJ 07055-7014
  • Manufacturer Parent Company (2017)
    Mwt Materials Inc.
  • Source
    USFDA