Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors
Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where unintended parameter changes could affect treatment accuracy, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Varian Medical Systems, Inc. is recalling the AlignRT Plus Optical Surface Monitoring System (OSMS). This system is used on Varian's TrueBeam EDGE to position and monitor patients relative to the prescribed treatment isocentre and to automatically withhold the beam during radiation delivery.
The recall is due to reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This issue can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with the OSMS.
The recall affects 21 AlignRT Plus units in the United States and 1 unit internationally. Distribution includes the US (nationwide) and countries including Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and the United Kingdom. Affected units are identified by specific serial numbers listed in the agency record.
The recalled product
- Product
- Optical Surface Monitoring System{Align RT Plus} 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…
- Manufacturer
- Varian Medical Systems, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Varian Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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