Optical Surface Monitoring System{Align RT Plus} This recall
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…
Why was Optical Surface Monitoring System{Align RT Plus} 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].
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
TrueBeam version 2.0/2.5 with any version OSMS. AlignRT Serial Numbers: 247-0200 247-0209 248-0013 248-0057 248-0070 249-0057 249-0066 249-0163 249-0164 249-0195 249-0226 249-0274 249-0050 249-0286 249-0277 248-0044 249-0227 247-0208 249-0047 247-0218 248-0050 248-0043 248-0048 249-0293 249-0155.
- 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…
- Recalling firm
- Varian Medical Systems, Inc.
- Quantity
- 21 AlignRT Plus in US, 1 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.
- Recall date
- July 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)