Optical Surface Monitoring System (OSMS) (2018-08-10)

Starting date:

August 10, 2018

Posting date:

August 31, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67616

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  Reason
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  Affected products

Affected products

Optical Surface Monitoring System (OSMS)

Reason

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.

Affected products