Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optical Surface Monitoring System{OSMS Recalled by Varian Medical Systems, Inc. Due to Varian Medical Systems has received reports that unintended...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Varian Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 166 OSMS in US, 23 OSMO - International,
Why Was This 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].
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Varian Medical Systems, Inc.
Varian Medical Systems, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report