ProductGuru Recalls

Official recall record

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: L

US FDA — Medical Devices · 2025-12-12 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2025-12-12
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
07340048311878
Brand on record
Elekta, Inc.

What the authority reported

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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