PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 20, 2016 Initiated: June 23, 2016 #Z-2149-2016

Product Description

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.

Reason for Recall

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].

Details

Units Affected
166 OSMS in US, 23 OSMO - International,
Distribution
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.
Location
Palo Alto, CA

Frequently Asked Questions

What product 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.. Recalled by Varian Medical Systems, Inc.. Units affected: 166 OSMS in US, 23 OSMO - International,.
Why was this product 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].
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2149-2016.

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