Events

Recall of Siemens MAGNETOM Aera magnetic resonance system

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
    68221
  • Event Risk Class
    Class 2
  • Event Number
    Z-1663-2014
  • Event Initiated Date
    2014-04-24
  • Event Date Posted
    2014-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127164
  • 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
    Siemens discovered a processing error for the magnetom aera magnetic resonance system that may have resulted in some users not receiving operator manuals.
  • Action
    A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.

Device

Siemens MAGNETOM Aera magnetic resonance system
  • Model / Serial
    model # 10432914 with serial numbers: 52126 52135 52108 52025 52101
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MN, CA, CO, TX, and IA.
  • Product Description
    MAGNETOM Aera magnetic resonance system. || Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
  • 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