Health Canada — Medical Devices · Canada · 2017-09-05 · Type II
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Reported risk: The issue is caused by the measured source paths for the following applicators: ring applicator sets, ring CT/MR applicator sets, interstitial CT/MR rings, Vienna CT/MR rings and advanced gynecological applicator - Venezia with lunar-shaped ovoids, which have a source step size of 2.5 mm for the Microselectron Afterloader. If you use such an applicator model to create a plan, while the default step size of the Afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. They will be shown as 2.5 mm, while the Afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
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