Events

Recall of Device Recall Magnetom Espree System with 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
    37760
  • Event Risk Class
    Class 2
  • Event Number
    Z-0769-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51474
  • 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 with OR table - Product Code LNH
  • Reason
    If table top is not seated properly it can lock up/stick.
  • Action
    The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.

Device

Device Recall Magnetom Espree System with OR Table
  • Model / Serial
    Model number 10092082, serial number 1002, 1003, and 1004.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in NY and TX.
  • Product Description
    Magnetom Espree System with OR Table
  • 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