Retiro De Equipo (Recall) de Device Recall TrueBeam Radiotherapy Delivery System and EDGE Radiotherapy Delivery System,

Recall

74607

Class 2

Z-2668-2016

2016-06-30

Terminated

United States

2017-09-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148234

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.

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.