Events

Recall of Device Recall Siemens

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
    67016
  • Event Risk Class
    Class 2
  • Event Number
    Z-1202-2014
  • Event Initiated Date
    2013-12-05
  • Event Date Posted
    2014-03-27
  • 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=124517
  • 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
    There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the artis q and artis q biplane systems with a flat detector as 40 hdr (large 30x40).
  • Action
    Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.

Device

Device Recall Siemens
  • Model / Serial
    model numbers 10848280, 10848281, 10848282, and 10848283.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
  • Product Description
    Siemens Artis Q and Artis Q biplane systems || Product Usage: Interventional Fluoroscopic X-ray
  • 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