Events

Recall of Device Recall ARTISTE" syngo RT Therapist (RRT)

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
    64214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0907-2013
  • Event Initiated Date
    2013-01-17
  • Event Date Posted
    2013-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115590
  • 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
    Siemens became aware of a potential safety issue when using the "in-session resumption" feature of the syngo rt therapist (rtt) 4.3 software. the rtt 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 via mail to all its direct consignees, informing them of the affected product issue and providing instructions on the recall. The firm stated that the release of this UI TH005/13/S to distribute the Customer Safety Advisory Notice began on January 17, 2013.

Device

Device Recall ARTISTE" syngo RT Therapist (RRT)
  • Model / Serial
    All codes/units of ARTISTE model.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    5 devices, all located outside of the United States in Germany.
  • Product Description
    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
  • 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