Events

Recall of Device Recall Artis zee

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
    80286
  • Event Risk Class
    Class 2
  • Event Number
    Z-2310-2018
  • Event Initiated Date
    2018-05-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165055
  • 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
    After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
  • Action
    On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed. The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.

Device

Device Recall Artis zee
  • Model / Serial
    147763 147573 147608 147760 147636 147630 147208 147514 147165 147558 147304 146946 147585 147553 147645 147087 147203 147601 147659 147675 147516 147700 147745 147681 147795 147773 147789 147541 147577 147029 147625 147635 146152 147660 147753 147083 146861 147561 147771 147657 147364 147775 147790 147781 147734 146896 147559 147620 147287 147749 147633 147737 147621 147250 147253 147252 147251 147717 147778 147643 147670 147234 147557 147661 147235 147716 147739 147743 147752 147528 147687 146867 147186
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
  • 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