Events

Recall of Device Recall ARTIS zee and zeego

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
    65651
  • Event Risk Class
    Class 2
  • Event Number
    Z-1782-2013
  • Event Initiated Date
    2013-06-26
  • Event Date Posted
    2013-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119815
  • 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
    Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on artis systems with artis vc20x/vc21a that have patch 7 and a 3d and dsa license installed. the issue affects-dsa rotational acquisition. the restriction is related to any rotational 3d-acquisition program with real-time subtraction (e.G. 3d dsa). during the fill phase of the rotational aqui.
  • Action
    Siemens sent a Customer Safety Advisory Notice dated June 26, 2013, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were strongly recommend to carefully evaluate one of the following options before running 3D rotational acquisition programs that include real-time subtraction until a patch is installed on their system: 1) position the monitor in a way such that contrast advancement can be monitored during the fill phase on the live monitor in the control room. 2) For applications not requiring actions based on the contrast flow during the fill phase, the contrast may not need to be monitored during the fill phase. Although the monitor is not showing the expected subtraction, the acquisition is working correctly. There is no need to interrupt, but continue and finish the workflow. 3) Perform 3D rotational programs that include real time subtraction from the exam room. The display on the live monitor in the exam room is not affected by this problem. To resolve the issue, the update AX028/13/P (VC20x/VC21B), will be made available around July 2013, and scheduling an appointment for implementation of the update with Siemens Customer Service organization was recommended. If this device/equipment is no longer in theirr possession, customers were asked to forward this safety notice to the new owner and inform Siemens of the new user's identity.

Device

Device Recall ARTIS zee and zeego
  • Model / Serial
    Model numbers: 10094137, 10094139, 10094141, 10280959
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Product Description
    ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. || Angiographic 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