Events

Recall of Magnetom Trio TIM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    36804
  • Event Risk Class
    Class 2
  • Event Number
    Z-0226-2007
  • Event Initiated Date
    2006-10-12
  • Event Date Posted
    2006-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49380
  • 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
    magnetic resonance imaging - Product Code LNH
  • Reason
    Possible excessive rf exposure/may burn.
  • Action
    The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions MR038/06/S. The letter informs customers of the potential issue and instructs them not to use the involved coils until this issue can be corrected.

Device

Magnetom Trio TIM
  • Model / Serial
    Model number 10018221. Serial numbers 35114, 35115, and 35177. Model number 10018222. Serial numbers 35025, 35006, 35022, 35008, 35014, and 35019.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Magnetom Trio TIM, magnetic resonance imaging
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA