XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
FDA device recall Z-2604-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.
- Action taken
- A Safety Notice, dated 5/20/10, was sent to Elekta / Computerized Medical Systems Inc clients in May 2010. The notice indicates the problem, the clinical impact. The notice states a future XiO Release will resolve the issue. A return postcard is included with the mailing to verify consignee received the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via phone or email to confirm receipt of the notice. The notice also informed the consignees they would be contacted when a solution was available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 57
- Distribution
- Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil,
- Date initiated
- 2010-05-19
- Date posted
- 2011-06-20
- Date terminated
- 2014-04-02
- 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 |