FDAJune 23, 2016device
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation de...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
What to do
FDA enforcement status: Terminated
Brands named
varian medical systemsvarianvarian medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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