Siemens Medical Solutions USA, Inc 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 t Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.