U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Accelerator, linear, medical - Product Code IYE
원인
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.
조치
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.
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.
제품 설명
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.