Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes
Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.
What this means for you
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 medical device where unintended parameter changes could lead to improper patient positioning during radiation therapy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling the Optical Surface Monitoring System (OSMS), a Varian Private Label product used with the TrueBeam EDGE radiation therapy system. The recall involves 166 units in the United States and 23 units internationally, distributed in countries including Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and the United Kingdom.
The recall was initiated after reports indicated 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 planned rotation while performing patient alignment with the OSMS. The affected systems are TrueBeam version 2.0/2.5 with any version of the OSMS.
Healthcare facilities using the affected equipment should contact Varian Medical Systems for instructions on how to address the issue. The specific serial numbers for the affected OSMS units are listed in the official recall documentation.
The recalled product
- 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 automaticall
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Varian Medical Systems, Inc.
See all →- HighVarian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure
FDA (Devices) · 2020-05-13
- HighVarian Eclipse Treatment Planning System Proton Algorithm Recall
FDA (Devices) · 2019-01-30
- HighVarian Eclipse Treatment Planning System Software Recall for Contouring Errors
FDA (Devices) · 2017-01-18
- HighVarian Head Frame Posts Recalled Due to Rotation Risk
FDA (Devices) · 2016-10-19
- HighVarian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors
FDA (Devices) · 2016-07-20
Same hazard · improper positioning
See all →- HighPRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall
FDA (Devices) · 2025-07-02
- HighKnee implant system recall due to aseptic loosening from improper surgical technique
FDA (Devices) · 2023-05-10
- HighLINK SLED Knee System Tibial Component Recall Due to Surgical Technique Issues
FDA (Devices) · 2023-05-10
- HighWaldemar Link LINK STEM Reconstruction Prosthesis Recalled for Depth Defect
FDA (Devices) · 2019-01-23
- ModerateMed Tec Recalls CIVCO Shoulder Retractors Due to Excessive Strap Length
FDA (Devices) · 2015-09-23