Events

Recall of Device Recall Siemens Axiom Artis zeego systems

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
    64684
  • Event Risk Class
    Class 2
  • Event Number
    Z-0992-2013
  • Event Initiated Date
    2012-11-26
  • Event Date Posted
    2013-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116768
  • 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
    In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an artis zeego system with software revision vc14, vc20 and vc21 in conjunction with a specific technical configuration which cannot be completely executed.
  • Action
    Siemens sent an Urgent Customer Information letter dated November 8, 2012 to affected consignees. The letter notified consignees of the issue and informed them the update AX039/12/S would be started and affected systems would be checked and corrected if required. Customers were instructed that they would be contacted to arrange a date for checking their system. For questions regarding this recall call 610-219-6300.

Device

Device Recall Siemens Axiom Artis zeego systems
  • Model / Serial
    Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.
  • Product Description
    Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration || Angiographic x-ray 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