Z-0433-2026Class II

Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version...

Name: Z-0433-2026 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version...
Creator: Elekta, Inc.
Published: 2025-09-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2025-09-30 / Open, Classified

FDA source

Elekta, Inc. began a recall of Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of... on 2025-09-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0433-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-30
Posted: 2025-11-05
Recalling firm: Elekta Limited
Product: 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.
Product code: HAW Neurological Stereotaxic Instrument
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
FDA root cause: Process change control
Action: On 09/30/2025, the firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that specified serial numbers, there is an increased risk that paint flakes from the engravings may separate from the Leksell Vantage Arc System components. Separation of paint flakes is likely to occur during cleaning and sterilization. If paint flakes are not washed away during the cleaning and sterilization process, these could remain on the Leksell Vantage Arc System when used in surgery. This poses a risk of paint flakes entering the surgical area. This situation has not been observed in clinical practice, but the risk should be fully considered and mitigated.
Quantity in commerce: 338
Distribution: 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.
Product codes and lots: Lot Code: UDI References: Arc: 07340048304856 Support Arc: 07340048304849 Arcs and Support Arcs with Serial Numbers: SH00001-SH00338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0433-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0433-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-05

Product code HAW

K190887Class IILeksell Vantage Stereotactic SystemElekta Instrument AB / cleared 2019-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)