Home / Recalls / Elekta, Inc. / Z-0433-2026

Z-0433-2026 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

FDA device recall Z-0433-2026 was initiated by Elekta, Inc. on September 30, 2025 and is designated Class II. Reason for recall: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound The recall status is ongoing. Affected quantity: 338.

Recall Details

Product Type
Devices
Report Date
November 12, 2025
Initiation Date
September 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
338

Product Description

Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Reason for Recall

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Code Information

Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338

Other recalls by Elekta, Inc.

  • Z-2406-2026 Class II — MOSAIQ Oncology Information System (May 21, 2026)
  • Z-2711-2026 Class II — Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Appli (April 3, 2026)
  • Z-2712-2026 Class II — Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: (April 3, 2026)
  • Z-2710-2026 Class II — Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary (April 3, 2026)
  • Z-2006-2026 Class II — Brand Name: Leksell Vantage Arc System REF: 1053958 (March 19, 2026)
  • Z-1581-2026 Class II — Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfe (February 18, 2026)
  • Z-1164-2026 Class II — Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele (December 14, 2025)
  • Z-1340-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1339-2026 Class II — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning (December 12, 2025)
  • Z-1078-2026 Class II — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4 (December 10, 2025)

FDA data resources