Elekta Gamma Knife Esprit Recall - Adapter Lock Issue
Summary
FDA has issued a Class II medical device recall for Leksell Gamma Knife systems manufactured by Elekta, Inc. due to an adapter lock defect affecting 847 units distributed nationwide. The recall impacts multiple models including Perfexion, Icon, and Elekta Esprit systems. Healthcare facilities using these radiation therapy systems must identify affected units and contact the manufacturer for corrective action.
What changed
FDA has classified a Class II recall for Leksell Gamma Knife systems (Perfexion, Icon, Esprit) manufactured by Elekta, Inc. affecting 847 units distributed in the U.S. The recall was initiated due to the adapter not being properly aligned or locked in place, which may compromise device performance during stereotactic radiosurgery procedures.
Healthcare facilities using these radiation therapy systems should immediately verify whether they possess affected units and contact Elekta to schedule corrective action. Failure to address the adapter lock defect could result in improper device operation during critical neurosurgical procedures. The recall is ongoing and applies to all states with U.S. distribution.
What to do next
- Identify if your facility has Leksell Gamma Knife Perfexion, Icon, or Esprit units from the affected lot
- Contact Elekta, Inc. for corrective action and adapter replacement
- Report any adverse events related to adapter lock failures to FDA
Archived snapshot
Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Elekta, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1581-2026 · 20260325 · Ongoing
Product
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models El...
Reason for Recall
Due to adapter not being properly aligned or locked in place.
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC...
Source: openFDA Enforcement API
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