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U.S. Department of Health and Human Services

Class 2 Device Recall AlignRT Plus

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  Class 2 Device Recall AlignRT Plus see related information
Date Initiated by Firm June 23, 2016
Date Posted July 11, 2016
Recall Status1 Terminated 3 on August 24, 2018
Recall Number Z-2150-2016
Recall Event ID 74585
510(K)Number K123371  
Product Classification Accelerator, linear, medical - Product Code IYE
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 position
and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
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. 
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer 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].
FDA Determined
Cause 2		 Software design
Action The firm, Visionrt, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTIFICATION" letter dated June 24, 2016 to all affected customers. Letters describe the product, problem and actions to be taken. The customers were instructed as follows: DO NOT USE the "Move Couch" function if the couch rotation value set in the AlignRT device DOES NOT match the planned couch rotation for the treatment field; retain a copy of this document along with your most current product labeling; pass the letter to all those who need to be aware of it within their organization; always confirm that the patient is correctly aligned prior to commencing treatment; is not required to return their devices; promptly inform Vision RT if they believe that patient harm occurred, and complete Appendix 1- Customer Acknowledgment Response and return it via email to corrections@visionrt.com. Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866-778-2379 from the US) or as per http://www.visionrt.com/contact/details.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VISION RT LIMITED
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