Events

Recall of Vantage Titan 3T MRI System, MRT3010A/5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems 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
    66725
  • Event Risk Class
    Class 2
  • Event Number
    Z-0201-2014
  • Event Initiated Date
    2013-10-28
  • Event Date Posted
    2013-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123182
  • 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
    Toshiba america medical systems, inc. is recalling due to a potential problem with specific absorption rate (sar) values when using the toshiba titan 3t system. when the system is used in combination with either the qd head coil (mjqh-142a) or the large knee speeder (mjaj-182a), sar values lower than the actual sar values may be displayed on the operating monitor.
  • Action
    Toshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information.

Device

Vantage Titan 3T MRI System, MRT3010A/5
  • Model / Serial
    Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
  • Product Description
    Titan 3T MRI System, MRT-3010A/5. || Product Usage: Usage: || MRI system.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA