Medical device licence · 15016 · Class 3
LEKSELL GAMMAPLAN
Yes: licensed in Canada
Licence status Issued (active); first licensed December 6, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 15016
- Licence holder
- Elekta Solutions AbStockholm, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- December 6, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEKSELL GAMMAPLAN
- LEKSELL GAMMAPLAN V.11
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “leksell”. A notice may cover another product or only some lots: read it to see what it covers.
- Leksell Gamma KnivesFebruary 18, 2026 · Radiology · Performance · Type II
- Leksell GammaPlan®December 23, 2025 · Radiology · Performance · Type II
- LEKSELL GAMMA KNIFE PERFEXION (2016-04-18)April 22, 2016 · Medical devices · Medical devices · Type II
- Leksell Gamma Knife Perfexion (2014-10-06)October 10, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.