Elekta, Inc.: Device Recall
Recall #Z-0433-2026 · 09/30/2025
Recall Details
- Recall Number
- Z-0433-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Elekta, Inc.
- Status
- Ongoing
- Date Initiated
- 09/30/2025
- Location
- Atlanta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338
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
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.
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.
Other Recalls by Elekta, Inc.
- Class II: Risk 12/14/2025
- Class II: Risk 12/10/2025
- Class II: Risk 01/15/2025