Health product recall

Elekta Infinity, Elekta Synergy and Versa Hd

Last updated

Summary

Product
Elekta Infinity, Elekta Synergy and Versa Hd
Issue
Medical devices - Performance issue
What to do

Contact ELEKTA_GLOBAL_PMS@ELEKTA.COM if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Elekta Infitiny No lot numbers XRT1501 XRT1511
Versa Hd No lot numbers XRT 20319 XRT 20419
Elekta Synergy No lot numbers XRT1412 XRT1402

Issue

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iviewgt™ / xvi detector arms. when the detector arm is fully deployed there is no risk of uncontrolled extension.

Recall start date: October 25, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Elekta Solutions Ab
Kungstensgatan 18, Stockholm, Sweden, 10393

 

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-74552