Events

Recall of Device Recall Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Conn

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
    56344
  • Event Risk Class
    Class 2
  • Event Number
    Z-1523-2011
  • Event Initiated Date
    2010-06-29
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93276
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    A software problem that has the potential for data loss during the transfer of treatment records to the ois, which may not be recorded in mosaiq, and subsequently may lead to mistreatment.
  • Action
    Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, "Safety Advisory Letter. For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist. For questions regarding this recall call 925-602-8157.

Device

Device Recall Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapis...
  • Model / Serial
    All codes.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.
  • Product Description
    Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA || Medical charged-particle radiation therapy system. || The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA