Events

Recall of Device Recall MAGNETOM Aera/Skyra

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
    59170
  • Event Risk Class
    Class 2
  • Event Number
    Z-2979-2011
  • Event Initiated Date
    2011-06-20
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101482
  • 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
    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
  • Action
    Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.

Device

Device Recall MAGNETOM Aera/Skyra
  • Model / Serial
    Model numbers 10432914 and 10432915
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.
  • Product Description
    MAGNETOM Aera/Skyra System - Nuclear 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA