Product Wiki · Recalls · Health Canada — Medical Devices

Optical Surface Monitoring System (OSMS) (2018-08-10) — recall 58557

Health Canada — Medical Devices · Canada · 2018-08-31 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58557
Date of alert
2018-08-31
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Vision RT have identified a potential issue which only affects OSMS systems that are integrated with a Varian TrueBeam linac (including STx and Edge). The risk relates to a Vision RT interface hardware failure during delivery, the likes of which have never been reported. This can only occur if a hardware fault occurs after beam-on has been asserted and during therapy. In this case the OSMS system would display if a patient moved out of tolerance as normal but the system would not gate the beam. However, due to the nature of the system's design, the system would not be able to reassert beam-on subsequently, so any unintended delivery of radiation could only ever happen to one patient in one field or arc.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/optical-surface-monitoring-sys

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