Elekta, Inc.: System, Radiation Therapy, Radionuclide
Recall Summary Elekta is recalling three models of the Leksell Gamma Knife radiosurgery system (used to deliver radiation treatment to brain tumors and other head conditions) because an adapter may not be properly aligned or locked in place during operation. The recall affects devices distributed worldwide, including throughout the United States. This is classified as a Class II recall, meaning the product could cause serious health problems or failure.
- Recalling firm
- Elekta, Inc.
- 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 Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
- Reason
- Due to adapter not being properly aligned or locked in place.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-18
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6486fcfb-0a4c-4f03-a7a5-589199a98a39