Events

Recall of Device Recall Artis zee angiographic xray 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
    77201
  • Event Risk Class
    Class 2
  • Event Number
    Z-2686-2017
  • Event Initiated Date
    2017-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155425
  • 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, angiographic - Product Code IZI
  • Reason
    Failures can result due to a component defect on artis zee systems with an a100 plus generator of a certain delivery lot and 2-focus megalix cat plus tube unit.
  • Action
    CDRH approved the CAP subject to the following conditions: 1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. 2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.

Device

Device Recall Artis zee angiographic xray system
  • Model / Serial
    Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
  • Product Description
    Artis zee,x-ray system, angiographic || Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
  • 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