Events

Recall of Artis Q, Q.zen, Artis zee, Artis zeego, Axiom Artis

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
    79214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-2018
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161665
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. if the foot switch fails, it will no longer be able to be used to release radiation. the hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
  • Action
    Letters were sent to all consignees with instructions to contact their service provider to arrange for an appointment to update the device hardware.

Device

Artis Q, Q.zen, Artis zee, Artis zeego, Axiom Artis
  • Model / Serial
    Serial Numbers: 10006 10010 10017 10025 10044 10050 10051 10055 1044 1078 1081 15000 15001 15018 15021 15032 15044 15047 15056 15058 15060 15076 15088 15091 15105 15114 15116 15131 15144 15148 15149 17002 17004 17007 17011 17032 17050 17061 17062 17074 17078 17084 17142 20001 20002 20005 20009 20015 20024 20030 21004 21006 21017 21022 21028 21033 21039 21047 21052 21054 21075 21087 21089 21095 21096 21112 21114 21117 21132 21135 21150 21151 21173 21175 21178 21187 21188 21200 21201 21205 21208 21216 21225 21273 21274 21278 21281 21283 21294 21308 21309 21317 21327 21331 21337 21345 21347 21351 21352 21353 21363 21370 21377 21379 21384 21393 21400 21407 21414 21415 21421 21423 21425 21430 21440 21442 21444 21447 21448 21449 21450 21461 21462 21467 21473 21475 21484 21488 21494 21498 21500 21508 21509 21515 21519 21520 21523 21524 21536 21543 21550 21551
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.
  • Product Description
    Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA