Varian Medical Systems, Inc. recalls Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The Al…

Recall date

June 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2149-2016

FDA classification

Class II

Brand / firm

Varian Medical Systems, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.

Why it was recalled

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].

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 delivery.