Class 2 Device Recall AlignRT Plus private labelOSMS Varian

• Date Initiated by Firm: June 30, 2016
• Create Date: August 25, 2016
• Recall Status: Terminated on September 20, 2017
• Recall Number: Z-2667-2016
• Recall Event ID: 74607
• 510(K)Number: K123371
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: AlignRT¿ Plus [private label-OSMS] K123371: 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: Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519
• Recalling Firm/ Manufacturer: Vision RT Ltd; Dove House, Arcadia Avenue; London United Kingdom
• Manufacturer Reason for Recall: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
• FDA Determined Cause: Other
• Action: Vision RT Ltd will provide all affected AlignRT¿ Plus Users with an Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Non-responders will be notified again until we achieve 100% for North America and International consignees. Vision RT will make three (3) attempts using at least two different methods of contact to obtain proof of notification. Containment: Vision RT will provide a copy of the Urgent Medical Device Correction letter for any site accepting an AlignRT device. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Product will not be returned to Vision RT. Varian Medical Systems and Vision RT are investigating development of a technical fix for the affected products. Notification of the intention to correct is provided in the Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. Vision RT Ltd will contact all affected AlignRT¿ Plus users and schedule upgrades to implement the correction when available.
• Quantity in Commerce: 47
• Distribution: Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
• 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