Events

Recall of Device Recall Magnetom Espree Sytem with Swiveling OR Table

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
    45986
  • Event Risk Class
    Class 2
  • Event Number
    Z-0518-2008
  • Event Initiated Date
    2007-11-05
  • Event Date Posted
    2008-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66619
  • 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
    Magnetic Resonance Imaging System, - Product Code LNH
  • Reason
    Table may experience a deadlock situation.
  • Action
    The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.

Device

Device Recall Magnetom Espree Sytem with Swiveling OR Table
  • Model / Serial
    Serial Numbers 1002, 1003, 1004, and 1007
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in TX and NY.
  • Product Description
    Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA
  • 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