Home / Recalls / Varian Medical Systems, Inc. / Z-2150-2016

Z-2150-2016 Class II Terminated

Recalled by Varian Medical Systems, Inc. — Palo Alto, CA

Recall Details

Product Type
Devices
Report Date
July 20, 2016
Initiation Date
June 23, 2016
Termination Date
August 24, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 AlignRT Plus in US, 1 International.

Product Description

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 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].

Distribution Pattern

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.

Code Information

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.

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