XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer pati
FDA device recall Z-2408-2011 · posted 2011-06-03 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.
- Action taken
- Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000.
- Root cause
- Software design
- Status
- Terminated
- Product code
- muj
- Quantity affected
- 1377
- Distribution
- Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, B
- Date initiated
- 2010-09-10
- Date posted
- 2011-06-03
- Date terminated
- 2014-04-08
- Location
- Maryland Heights, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIO RTP SYSTEM (K092132) | Computerized Medical Systems, Inc. | 2009-09-24 |