Recalls / —
—#43217
Product
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.
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K981313
- Affected lot / code info
- 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
Why it was recalled
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.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 4040 Nelson Ave, Concord, California 94520-1200
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2005-01-06
- Posted by FDA
- 2006-01-07
- Terminated
- 2006-05-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.