Events

Recall of Device Recall 550 TxT Treatment Tables which are used in PRIMUS, ONCOR, ARTISTE Linac systems

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
    67126
  • Event Risk Class
    Class 2
  • Event Number
    Z-0787-2014
  • Event Initiated Date
    2013-12-05
  • Event Date Posted
    2014-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124745
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Reason
    Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 txt treatment table. combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the txt" treatment table has been damaged due to contacting a moving part. the resulting short-circuit cau.
  • Action
    The firm, Siemens, sent a "Medical Device Correction" letter to affected users/customers starting on December 5, 2013 via Federal express. The letter described the product, problem and actions to be taken. Siemens has arranged for modification of the affected 500 TxT Treatment Table. A service representative will modify the mounts of the TT-A, TT-D, TT-M, or TT-s table tops ( Pleases note that this modification only applies to the Siemens provided table tops TT-A, TT-D, TT-M, and TT-S.). In addition, the Siemens service representative will modify the cable routing inside of the patient table base. The customers were instructed to include this Field Safety Notice in your Digital Linear Accelerator System Owner manual chapter 'Safety Advisory Letters' where it should remain. If you have any questions, please contact the Senior Manager, Regulatory Affairs at 1-925-293-5442 or email: christine.dunbar@siemens.com.

Device

Device Recall 550 TxT Treatment Tables which are used in PRIMUS, ONCOR, ARTISTE Linac systems
  • Model / Serial
    550 TxT table - part number 07346534.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
  • Product Description
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. || TT-A, TT-D, TT-M or TT-S Table tops. || Manufactured by: || SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse 19-21 || Kemnath, GERMANY 95478 || 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, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA