Events

Recall of Device Recall LANTIS software

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
    34166
  • Event Risk Class
    Class 2
  • Event Number
    Z-0364-06
  • Event Initiated Date
    2005-01-06
  • Event Date Posted
    2006-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43217
  • 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 using the creatine clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. this miscalculation may result in patients less than two years old to be seriously overdosed with radiation.
  • Action
    The firm has sent out notification letters to the 18 sites with the activated MedOnc option. All 18 site had the letters delivered by Siemens Medical Solutions field service personnel by 1/6/2005.

Device

Device Recall LANTIS software
  • Model / Serial
    Serial #: 93-0001, 93-0016, 93-0027, 93-0289, 93-0304, 93-0306, 93-0333, 93-0368, 93-0430, 93-0436, 93-0549, 93-0639, 93-0641, 93-0652, 93-0664, 93-0703, 93-0718 and  93-0786
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    A total of 18 sites were identified by the firm as having the MedOnc module activated; 6 within the United States U.S.) and 12 outside of the U.S.
  • Product Description
    LANTIS software with MedOnc Module; || MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radiation therapy to cancer patients. || The MedOnc module is distributed by Siemens Medical Solutions USA ¿ Oncology Division, 4040 Nelson Avenue, Concord, CA 94520 with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. || Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., 100 West Evelyn Avenue, Mountain View, CA 94041 (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
  • 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