Health product recall

Leksell GammaPlan®

Last updated

Summary

Product
Leksell GammaPlan®
Issue
Medical devices - Performance
What to do

Elekta will notify affected customers of safety notice 100-01-102-019 via email, with follow-up contacts as needed. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Leksell GammaPlan® Not applicable. VERSION 11.4

Issue

Defining a new stereotactic reference for a frame treatment without first changing an existing obsolete reference to a pre-plan reference may create inconsistent alignment and, if not detected, lead to irradiation of the wrong patient location.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Elekta Solutions AB

Hagaplan 4, Stockholm, Sweden, 11368

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81399

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