Health product recall

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

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

Optical Surface Monitoring System (OSMS)

Lot or serial number

249-0502
249-0607
249-0643
249-0675
249-0676
249-0678
249-0682
249-0701
249-1512
249-1519
249-1573
249-1574

Model or catalog number

OSMS

Companies
Manufacturer
VISION RT LIMITED
DOVE HOUSE, ARCADIA AVENUE
LONDON
N3 2JU
UNITED KINGDOM