device · product 1 of 1
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.
- Recall number
- Z-0433-2026
- Initiated
- September 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Elekta, Inc.
- Quantity
- 338
App-derived interpretation
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
Official device-enrichment evidence · Sourced
Process change control
Inspect official wording and provenance
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
Code information
Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338
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.