Reported Jul 20, 2016 · Terminated
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE
- RadiologyThe 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
- Lot codes and dates
- TrueBeam version 2.0/2.5 with any version OSMS
- AlignRT Serial Numbers
247-0200247-0209248-0013248-0057248-0070249-0057249-0066249-0163249-0164249-0195249-0226249-0274249-0050249-0286249-0277248-0044249-0227247-0208249-0047247-0218248-0050248-0043248-0048249-0293249-0155
- Amount recalled
- 21 AlignRT Plus in US, 1 International.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was 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].
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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