Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell Gam

FDA device recall Z-1581-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Due to adapter not being properly aligned or locked in place.

Action taken

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 with the docking device. Reference instructions for use and warnings: Warning 4.1 - After locking the docking device, make sure that the adapter is correctly attached and securely locked to the patient positioning system. if the adapter is not correctly locked, it may affect the accuracy and lead to clinical mistreatment, or cause patient injury. All Customer must print/save this page and add it to their existing IFU file. For questions - Contact Region America at Application.Support.NA@elekta.com or telephone +1 855-693-5358

Root cause

Use error

Status

Open, Classified

Product code

IWB

Quantity affected

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,

Date initiated

2026-02-18

Date posted

2026-03-19

Location

Atlanta, GA

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