LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software di
FDA device recall Z-0364-06 · posted 2006-01-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- 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.
- Date initiated
- 2005-01-06
- Date posted
- 2006-01-07
- Date terminated
- 2006-05-15
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |