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Open, Classified

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.

FDA Recall Z-1581-2026 · Posted 2026-03-19

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIWB
Date Initiated2026-02-18
Product Quantity352

Reason for Recall

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

Firm 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 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 [email protected] or telephone +1 855-693-5358

Root Cause

Use error

Distribution Pattern

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, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions AB · 2025-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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