Events

Recall of Device Recall Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging 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
    61760
  • Event Risk Class
    Class 2
  • Event Number
    Z-1675-2012
  • Event Initiated Date
    2012-03-30
  • Event Date Posted
    2012-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108940
  • 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
    There is an error in the compatibility data sheet which is part of the system owner manual.
  • Action
    Siemens issued a Customer Safety Advisory Notice letter to affected customers on March 30, 2012. The letter identified the affected product, problem, potential risk and what steps can the user take to avoid the potntial risk of this issue. Siemens is releasing corrected pages of the Operator Manual in order to deliver clear guidance and recommendation for the users. Customers are instructed to ensure that the safety advisory and updated pages are replaced in the System Owner Manual.

Device

Device Recall Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System
  • Model / Serial
    Serial numbers 38293, 38036, 38044, 38096, 38108, 38144, 49011, 38054, 38045, 38184, 38003, 38416, 38334, 38206, 38048, 38183, 38109, 38010, 38301, 38090, 38242, 38014, 38049, 38067, 38105, 38254, 38035, 38375, 38182, 38554, 38075, 38171, 38046, 38340, 38428, 38240, 38130, 38148, 38621, 38247, 38058, 38189, 38201, 38204, 38311, 38106, 49213, 38315, 38299, 49169, 38470, 38256, 38117, 38043, 38059, 38276, 49248, 38295, 38381, 38052, 38478, 38191, 38091, 38362, 38047, 38322, 38368, 38145, 38393, 38455, 38372, 38033, 38209, 38417, 38164, 38015, 38042, 49167, 38538, 38125, 38447, 38155, 38071, 38482, 38020, 38057, 38092, 38312, 38253, 38196, 38346, 38027, 28066, 38325, 38365, 38074, and 38429.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MS, MO, NE, NJ, NY, NC, OH, OR, PA, TN, TX, WA, WI, WY and Puerto Rico.
  • Product Description
    Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System || Product Usage: || 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