Elekta recalls specific Leksell Vantage Stereotactic System models due to potential improper locking mechanism function at the Instrument Carrier and Arc interface.
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Elekta is recalling certain Leksell Vantage Stereotactic Systems because the locking mechanism between the Instrument Carrier and Arc might not work properly. This could lead to improper system function during medical procedures.
The locking mechanism at the interface of the Instrument Carrier and Leksell Vantage Arc may not function properly, potentially causing improper system alignment during medical procedures. This could lead to inaccurate targeting or unintended movement of surgical instruments.
Medical professionals using the Leksell Vantage Stereotactic System for neurosurgery are most at risk. Patients undergoing procedures with these specific models may be affected.
Check for serial numbers listed in the recall: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, and other specific serial numbers provided in the recall notice.
Verify if your Leksell Vantage Stereotactic System has a serial number from the list provided in the recall notice.
The locking mechanism at the interface of the Instrument Carrier and Leksell Vantage Arc may not function properly, potentially causing improper system alignment during medical procedures.
Check for serial numbers listed in the recall: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, and other specific serial numbers provided in the recall notice.
The recall does not specify a remedy, so contact Elekta directly for guidance on next steps.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2442-2020 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2442-2020 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.
