Recall of Device Recall LANTIS Oncology Information 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
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    When editing the note type of a previously entered note, then reverting to the original type, data may be lost.
  • Action
    Siemens sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to configure their system to lock all new notes automatically. To automatically lock new notes, open eChart Navigator, right mouse click in the notes section, select "configuration" and select "Automatically Lock New Notes." If the customer chooses not to configure their system to automatically lock new notes, follow at least one of the suggestions listed below: If the customer must edit a note type, use the append feature and document that they are making an edit to the note. Lock all new notes that are entered via eChart Notes. To lock a note manually, after creating the note, right mouse click and select "Lock," Access and enter patient notes via eChart Notes until a LANTIS upgrade has been performed at your site. When entering patient notes via eChart Navigator, make sure that you are entering the notes in the correct section.\ When entering patient notes via eChart Notes, make sure that the correct note type has been selected. Customers are to keep the Customer Safety Advisory Notice together with their LANTIS 8.30 User Manual where it should remain until the measures defined above are performed. For questions call 1-888-826-9702.


  • Model / Serial
    versions 8.3, CD# 9, 10 and 11, part numbers 8149259, 8164787, 8166527
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA including DE, WI, TX, TN, NJ, PA, NE, MA, and AL and the countries of South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan.
  • Product Description
    LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA || Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.
  • Manufacturer


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