Events

Recall of Device Recall Magnetom Harmony

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
    46245
  • Event Risk Class
    Class 2
  • Event Number
    Z-1042-2008
  • Event Initiated Date
    2007-12-01
  • Event Date Posted
    2008-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67972
  • 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
    Nuclear Magnetic Resonance Imaging System - Product Code LNH
  • Reason
    Magnet quench, unintended- magnet of a mobile mri system quenched into the exam room.
  • Action
    The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.

Device

Device Recall Magnetom Harmony
  • Model / Serial
    Serial Numbers: 10018, 10022, 10029, 10032 10036, 10160, 10167, 10255, 10289, 10316, 10386, and 10429.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355
  • 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