XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer pat
FDA device recall Z-2407-2011 · posted 2011-06-02 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.
- Action taken
- The firm, Elekta, issued an "important Safety Notice" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue. If you have any questions, please call 314-993-0003 or 800-878-4267.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 415
- Distribution
- Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, A
- Date initiated
- 2010-05-27
- Date posted
- 2011-06-02
- Date terminated
- 2014-04-10
- Location
- Maryland Heights, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIO RTP SYSTEM (K092132) | Computerized Medical Systems, Inc. | 2009-09-24 |