Recall of Device Recall LANTIS Commander, 10 Users, LANTIS 6.1 Commander and LANTIS 8.3 Commander

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
    70384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1282-2015
  • Event Initiated Date
    2015-01-21
  • Event Date Posted
    2015-03-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-07-30
  • Event Source
    USFDA
  • 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
    There is a potential safety risk when using lantis server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the patient.
  • Action
    Siemens sent an Customer Advisory Notice, dated January 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed the risk associated with use of more recent operating systems with LANTIS Server Software. Customers were warned against the use of more recent operating systems to ensure the LANTIS system remains in the validated configuration. In the interest of safety, we ask you to perform the above preventive measures and inform all affected personnel immediately. Please include this Field Safety Notice in your System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority will be informed of this Field Safety Notice. Please forward this safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this customer notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this notice until the update has been fully completed. We apologize for any inconvenience and thank you for your cooperation. For further questions please call (610) 219-6300.

Device

  • Model / Serial
    Models: 04503178, 05493072, 08148178 with various serial numbers: 93-0938 93-1010 93-0730 93-0454 93-0759 93-0848 93-0884 93-1158 93-0037 93-1053 93-0726 93-0588 93-0693 93-0614 93-0566 93-0648 93-0803 93-0813 93-1387 93-0278 93-0856 93-0657 93-0222 93-1438 93-0662 93-0779 93-0732 93-0841 93-1045 93-0487 93-0564 93-0261 93-0096 93-0846 93-0574 93-0668 93-0887 93-1145 93-0102 93-0764 93-0501 93-0490 93-0739 93-1133 93-0159 93-0872 93-1531 93-0660 93-0798 93-0393 93-0738 93-1296 93-0623 93-0370 93-0951 93-0667 93-1135 93-0141 93-0786 93-0483 93-0385 93-1314 93-0799 93-0456 93-0416 93-0838 93-0639 93-0659 93-0760 93-0608 93-0766 93-0063 93-0878 93-0861 93-0452 93-0533 93-0272 93-0724 93-0596 93-0831 93-0398 93-0870 93-0874 93-0789 93-0686 93-0475 93-1185
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
  • Source
    USFDA