Events

Recall of Device Recall syngo RT Therapist and 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
    60461
  • Event Risk Class
    Class 2
  • Event Number
    Z-0462-2012
  • Event Initiated Date
    2011-11-02
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105463
  • 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
    The software release will bring current installed base system to the forward production version. it is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects.
  • Action
    Siemens sent Customer Information letters and Update Instructions TH024/11/S for the installation of software release 4.2.108 beginning on November 2, 2011 to all affected consignees. Sites with active devices for the Oncology system were sent the current Update Instructions TH014/11/S for the installation of software release 4.2.108 and Customer Information letter beginning November 22, 2011. Consignees were asked to include the Customer Information in their syngo RT Oncologist System Owner Manual chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 925-602-8157.

Device

Device Recall syngo RT Therapist and syngo RT Therapist
  • Model / Serial
    Part number 08162815 - syngo RT Therapist Part number 08168754 - syngo RT Therapist Connect/MOSAIQ OIS. Part number 10652131 - syngo RT Oncologist Part number 10658604 - syngo Suite for Oncology System.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worlwide Distribution - USA (nationwide) including UT, OH, TN, FL, WI, IN, KY, CA, PA, SD, NY and the countries of India, Germany, United Kingdom, Australia, Poland, Japan, Croatia, India, Columbia, Belgium, Puerto Rico, China, Sweden, South Africa and Czech Republic.
  • Product Description
    syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. || This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. || 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. || 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