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Leksell gammaplan®

Official notice

23 Dec 2025

Last checked

23 Dec 2025

Critical riskHealth Canada
Watch Elekta

An official Health Canada notice concerns Leksell gammaplan®. 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. Published 2025-12-23.

What to do now

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

Recall number

81399

Official notice

2025-12-23

The hazard

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.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Other

RA RA-81399

Recall Numbers

81399

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Affected products

Product 1

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

Product 2

Lot or serial number - Not applicable., Model or catalogue number - VERSION 11.4

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Elekta

Manufacturer

Not provided

Phone

Not provided

Brand: Elekta.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

81399

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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