Events

Recall of Device Recall Siemens Axiom Aristos FX and FX Plus System

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
    58110
  • Event Risk Class
    Class 2
  • Event Number
    Z-1959-2011
  • Event Initiated Date
    2011-02-17
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98367
  • 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, stationary - Product Code KPR
  • Reason
    During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all axiom aristos fx and fx plus systems with serial numbers up to and including 1216. when using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. if this occurs in vertical modes, the possibility exists that the detect.
  • Action
    The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.

Device

Device Recall Siemens Axiom Aristos FX and FX Plus System
  • Model / Serial
    Model numbers 10093864 and 7414803 -- Serial numbers up to and including 1216.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.
  • Product Description
    Axiom Aristos FX and FX Plus System || Intended use: Stationary 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