Z-2150-2016 Class II Terminated
FDA device recall Z-2150-2016 was initiated by Varian Medical Systems, Inc. on June 23, 2016 and is designated Class II. 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… The recall status is terminated (terminated August 24, 2018). Affected quantity: 21 AlignRT Plus in US, 1 International..
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.