Events

Recall of Device Recall Siemens

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
    67556
  • Event Risk Class
    Class 2
  • Event Number
    Z-1272-2014
  • Event Initiated Date
    2014-02-07
  • Event Date Posted
    2014-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125713
  • 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, angiographic - Product Code IZI
  • Reason
    Certain units of the axiom artis systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
  • Action
    Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.

Device

Device Recall Siemens
  • Model / Serial
    Model nos. 7412807, 7727717, 7728392 with serial numbers: 35020, 34999,35098 35113 35042 35061 35064 35073 35014 35069 35053 35055 35056 35054 35008 35057 35044 35018 35097 35108 35046 35048 35050 35045 35004 35019 46004 46005 40000 40009 40011 40006 40007 40010 44016 44005 44011
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
  • Product Description
    AXIOM Artis Systems || Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
  • 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