Recall Z-2593-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
| Date | Jun 20, 2011 (initiated May 27, 2010) |
| Status | Terminated |
| Reason | XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated. |
| Root cause | Software design |
| Action | Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available. |
| Quantity | 1400 |
| Distribution | Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Ri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |