Recall Monitor
Health Products

Leksell GammaPlan®

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel 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.

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