Events

Recall of Device Recall COHERENCE 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
    64675
  • Event Risk Class
    Class 2
  • Event Number
    Z-1040-2013
  • Event Initiated Date
    2013-03-05
  • Event Date Posted
    2013-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116750
  • 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
    Siemen's issued a customer information letter under update instruction th016/12s to alert all its affected customers of the software issues. the software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
  • Action
    Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released

Device

Device Recall COHERENCE RT Therapist
  • Model / Serial
    All units of these models.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; || Model: || Primeview 3i 2.0, Part No. 8139847, || Current R630; || Product Usage: || The intended use of the SIEMENS branded 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