Events

Recall of Device Recall LANTIS Verify and Record software with XLINK option for Varian MLC

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
    35982
  • Event Risk Class
    Class 2
  • Event Number
    Z-1401-06
  • Event Initiated Date
    2006-07-07
  • Event Date Posted
    2006-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47300
  • 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
    Impac MultiAccess Sequencer - Product Code IYE
  • Reason
    Improper treatment may be delivered if the machine configuration file is edited/set for the varian mlc revision h file format.
  • Action
    The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.

Device

Device Recall LANTIS Verify and Record software with XLINK option for Varian MLC
  • Model / Serial
    Site Numbers: 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland
  • Product Description
    LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

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