Recall of Device Recall Coherence AG 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Reason
    Image orientation incorrect (image shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) this problem occurs only when non-square reference images are used, such as when images are cropped. at this point, the images will refresh, and the center of the reference im.
  • Action
    On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.


  • Model / Serial
    Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
  • Product Description
    Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
  • Manufacturer


  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source