Device Recall AlignRT Plus 의 리콜

Recall

74585

Class 2

Z-2150-2016

2016-06-23

2016-07-11

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147985

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].

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.