Events

Recall of Device Recall Siemens Medical Somatom Computed Tomography System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Systems 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
    25075
  • Event Risk Class
    Class 2
  • Event Number
    Z-0322-03
  • Event Initiated Date
    2002-07-10
  • Event Date Posted
    2002-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25113
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    Head holder cannot be properly secured on the table top.
  • Action
    Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.

Device

Device Recall Siemens Medical Somatom Computed Tomography System
  • Model / Serial
    Somatom Sensation 4 -- Serial Numbers 28001 to 28070 Somatom Volume Zoom -- Serial Numbers 24006 to 24752 Somatom Volume Access -- Serial Numbers 26111 to 26123 Somatom Valance -- Serial Numbers 38169 to 38475 Somatom Emotion -- Serial Numbers 40354 to 40383 Somatom Emotion Duo -- Serial Numbers 36081 to 36126 Somatom Esprit -- Serial Numbers 34191 to 34213 Somatom Esprit+ -- Serial Numbers 35024 to 35039
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
  • Product Description
    Computed Tomography system, Diagnostic Imaging: || Somatom Sensation 4 || Somatom Volume Zoom || Somatom Volume Access || Somatom Balance || Somatom Emotion || Somatom Emotion Duo || Somatom Esprit || Somatom Esprit +
  • Manufacturer
    Siemens Medical Systems Inc

Manufacturer

Siemens Medical Systems Inc
  • Manufacturer Address
    Siemens Medical Systems Inc, 186 Wood Ave So, Iselin NJ 08830
  • Source
    USFDA