Elekta recalls Leksell Vantage Stereotactic System due to risk of paint flakes separating and entering surgical wounds during neurosurgery. Affected units have specific serial numbers.
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
Elek: The Leksell Vantage Stereotactic System software has a risk that paint flakes from engravings could separate and enter surgical wounds. This could cause complications during neurosurgery procedures.
Paint flakes from the device's engravings may separate and inadvertently enter the surgical wound during procedures. This could lead to complications or infections in the patient.
Surgical teams using the Leksell Vantage Stereotactic System for neurosurgery procedures. Patients undergoing these procedures are at risk if the paint flakes enter the wound.
Check for serial numbers SH00001 to SH00338 on the Leksell Vantage Stereotactic System. The product was sold with specific lot codes and serial numbers as listed in the recall notice.
Verify if your device has a serial number between SH00001 and SH00338.
The recall states there is a risk of paint flakes entering wounds, but the product is generally safe unless the paint flakes separate and enter the surgical site.
Check your device's serial number to see if it falls within SH00001-SH00338. If it does, contact Elekta for further instructions.
The recalled product has serial numbers from SH00001 to SH00338. Check the device's serial number label.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0433-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0433-2026 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
