Events

Recall of Device Recall AXIOM Artis and AXIOM Artis zee modular angiographic 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
    60989
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-2012
  • Event Initiated Date
    2012-01-16
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106994
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    There is a potential misalignment in the connection of the remote foot switch and the stationary unit. this potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. this is not a general issue but sporadic as a vendor unsystematical.
  • Action
    Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.

Device

Device Recall AXIOM Artis and AXIOM Artis zee modular angiographic systems
  • Model / Serial
    Model numbers 5904433, 5904441, 5904649, 5904656, 5904466, 7007755, 7728350, 7412807, 7727717, 7728392, 7413078, 7555373, 7555365, 7555357, 7008605, 5917054, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: CA, CT, FL, GA, HI, IL, IN, KY, ME, MD, MI, MS, MO, NH, NJ, NY, NC, OH, OR, TN, TX, UT, VA, WI and Puerto Rico.
  • Product Description
    AXIOM Artis and AXIOM Artis zee modular angiographic systems || Product Usage: Angiographic x-ray systems
  • 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