Elekta, Inc.
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