Events

Recall of Device Recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist

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
    62519
  • Event Risk Class
    Class 2
  • Event Number
    Z-2073-2012
  • Event Initiated Date
    2012-06-25
  • Event Date Posted
    2012-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110823
  • 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
    Potential safety issue when using the immediate resumption feature after a control console interlock during the delivery of flattening-filter-free (multiple-x) beams or segments. in a very rare scenario, the rt therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered monitor units of the same beam or segment.
  • Action
    The firm issued "Urgent: Medical Device Correction" letters delivered by the Siemens Customer Service Group or by certified mail to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm stated that release of this UI TH018/12/S to distribute the notifications began on June 25, 2012.

Device

Device Recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist
  • Model / Serial
    ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
  • Product Description
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used 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