Events

Recall of Device Recall Siemens Artis Zee Family

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
    67558
  • Event Risk Class
    Class 2
  • Event Number
    Z-1309-2014
  • Event Initiated Date
    2014-02-07
  • Event Date Posted
    2014-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125716
  • 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
    Angiographic x-ray system - Product Code IZI
  • Reason
    An inappropriate cable connection was assembled for certain artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
  • Action
    A recall notification letter dated February 7, 2014, was sent to End Users.

Device

Device Recall Siemens Artis Zee Family
  • Model / Serial
    Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
  • Product Description
    Artis Zee 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