Events

Recall of Device Recall Magnetom Trio

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
    28046
  • Event Risk Class
    Class 3
  • Event Number
    Z-0521-04
  • Event Initiated Date
    2003-12-18
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31101
  • 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
    Tissue roll can become magnetic.
  • Action
    The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder.

Device

Device Recall Magnetom Trio
  • Model / Serial
    Model #7387074 - Serial #''s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT.
  • Product Description
    Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device
  • 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