Leksell GammaPlan®
Brand(s)
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
Get notified
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