Official recall record

Leksell Gamma Knives

What the authority reported

When treating patients with the Leksell Gamma Knife®, the patient is attached to the device via an adapter. The adapter is the interface between the Leksell Gamma Knife® and the immobilization system used for the treatment. The Leksell Gamma Knife® has three types of adapters for patient fixation, the g-frame adapter, the vantage adapter, and the mask adapter. Elekta has become aware that a Quality Assurance (QA) procedure was initiated while the adapter was not properly locked to the patient positioning system of the Leksell Gamma Knife® as a result, the QA check failed.

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.

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