Company: Varian Medical Systems
Date of Enforcement Report 7/20/2016
Class lI:

PRODUCT

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.
Recall Number Z-2149-2016

REASON
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].

RECALLING FIRM/MANUFACTURER
Varian Medical System, Palo Alto, CA s on 6/23/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
166 OSMS in US, 23 OSMO – International,

DISTRIBUTION
Nationwide and Internationally

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