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Leksell Gamma Knife Radiosurgery System
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MEDICAL DEVICE RECALLMODERATE

Leksell Gamma Knife Radiosurgery System

Elekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit systems due to potential adapter misalignment during radiation delivery.

What to do

Contact your Elekta service representative to schedule an inspection and ensure the adapter is correctly aligned and locked.

Recalled
Listed
Updated
Recall No.
Z-1581-2026
Agency
FDA
Firm
Elekta, Inc.
Recall ID
98443
Status
ONGOING

Why it was recalled

Elekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit radiosurgery systems due to a risk that the adapter may not be properly aligned or locked in place. This issue could lead to inaccurate radiation delivery during stereotactic irradiation procedures. The recall is distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Leksell Gamma Knife

UDI-DI
07340048303019, 30002718, 30002934, 30000655, 30001910, 30000732, 30001270, 30001527

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Elekta, Inc.

All recalls from Elekta, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification