Events

Recall of Device Recall Siemens AXIOM Artis zeego

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
    65721
  • Event Risk Class
    Class 2
  • Event Number
    Z-1945-2013
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2013-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119960
  • 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
    Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the artis zeego system.
  • Action
    The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens. Update instruction AX012/13/S was issued, and a software update will be released as AX006/13/S and AX007/13/S which will modify the system software so that it will not be possible for information to be overlaid. If you have any questions call +49 (9191) 18 0.

Device

Device Recall Siemens AXIOM Artis zeego
  • Model / Serial
    Model number 10280959
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Siemens AXIOM Artis zeego || x-ray, angiographic system
  • 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