Events

Recall of Device Recall Artis zee/ zeego, Artis Q/ Q.zen

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
    74655
  • Event Risk Class
    Class 2
  • Event Number
    Z-2344-2016
  • Event Initiated Date
    2016-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148124
  • 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
    Due to an error in the 19 live display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
  • Action
    Siemens sent an Important Customer Safety Notice dated July 7, 2016, by certified mail to customers to inform them of the corrective action they plan to take to prevent potential loss of the image display for live images in the examination room after system startup. Siemens service organization will contact each customer to arrange a date to resolve the issue with a software update of the monitor firmware via AX012/16/S. For questions regarding this recall call 610-448-6461.

Device

Device Recall Artis zee/ zeego, Artis Q/ Q.zen
  • Model / Serial
    Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,109187,124102,121167,125021,121163,117125,148001,158234,148010,158229,121171, 109183,109181,131101,158226,109194,117124,158244,109179,158238,109188,121179,137714,121168,158246,161022,121175,121173,154859,109186,158230,123046,158227,109189,123052,105029,105030
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV
  • Product Description
    Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled || Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 || Artis zee / zeego and Q/ Q.zen 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen 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