Product Wiki · Recalls · Health Canada — Medical Devices

Eclipse TPS v11.0 (2016-01-11) — recall 55018

Health Canada — Medical Devices · Canada · 2016-01-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55018
Date of alert
2016-01-25
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: An anomaly was identified with Eclipse treatment planning system using pencil beam convolution (PBC) 11.0.31 to compute a conventional arc dose distribution. When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated monitor units (MU). All affected devices in Canada are at version 11.0.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/eclipse-tps-v110-2016-01-11

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