Company: Elekta inc.
Date of Enforcement Report:1/29/2014
Class lI:
PRODUCT
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Recall Number Z-0780-2014
REASON
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 11/25/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13
DISTRIBUTION
Nationwide and Internationally
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