Elekta recalls Leksell Vantage Arc System devices with potential shifting coordinates during procedures. Affected units have specific serial numbers and lot codes. Contact Elekta for remedy details.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Elekta is recalling Leksell Vantage Arc System devices that may shift coordinates during procedures due to faulty locking mechanisms. This could lead to inaccurate treatment outcomes in medical procedures.
The locking mechanisms in the Arc system may not secure properly, causing shifts in coordinates during medical procedures. This could result in inaccurate radiation targeting and potentially affect treatment outcomes.
Medical professionals using the Leksell Vantage Arc System for radiation therapy are most at risk. Patients receiving treatments with affected devices may experience inaccurate radiation delivery.
Check for the Leksell Vantage Arc System with serial numbers starting with UDI: 07340048304818 or 00001 00625 on the left Z-Slide and UDI: 07340048304801 or 00001 00675 on the right Z-Slide.
Verify the serial numbers on the left and right Z-Slides as listed in the recall notice.
The locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Check for specific serial numbers: Left Z-Slide UDI: 07340048304818 or 00001 00625, Right Z-Slide UDI: 07340048304801 or 00001 00675.
The recall notice does not specify a remedy, so contact Elekta directly for further instructions.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2006-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2006-2026 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.
