Events

Recall of Device Recall Siemens syngo RT Dosimetrist 2.7 system

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
    68395
  • Event Risk Class
    Class 2
  • Event Number
    Z-2075-2014
  • Event Initiated Date
    2014-05-15
  • Event Date Posted
    2014-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127508
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    An update to the virtual simulation software of the syngo rt dosimetrist is necessary to address a safety issue. in special scenarios within the structure operations function the system did not store the selected name from the list of predefined names. after reloading of the data, this structure name had been changed by the system. additionally, a performance issue was addressed where import of di.
  • Action
    Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.

Device

Device Recall Siemens syngo RT Dosimetrist 2.7 system
  • Model / Serial
    material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
  • Product Description
    Siemens syngo RT Dosimetrist 2.7 system || Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray 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, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA