Recall Z-1581-2026 · IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
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 radiati
| Date | Mar 19, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Due to adapter not being properly aligned or locked in place. |
| Root cause | Use error |
| Action | On 02/18/2026 and 02/24/2026, the firm sent via email an "IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION" letter to customers informing them that 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 and as a result, the QA check failed. Customers are instructed to: To prevent the risk of incorrect locking, it is important to always check that the patient is properly attached to the Leksell Gamma Knife. The adapter shall be perfectly aligned wit |
| Quantity | 352 |
| 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, Braz |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) Elekta Solutions AB, Jul 2, 2025 |