Elekta recalls Leksell Vantage Stereotactic System Instrument Carrier (serial numbers SH00106 to SH00178) due to a faulty locking piece that may not secure properly to the Arc system.
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Elekta is recalling a specific part of the Leksell Vantage Stereotactic System (serial numbers SH00106 to SH00178) because a faulty locking piece may not secure properly to the Arc system. This could lead to the instrument carrier not staying locked in place during use, potentially causing injury.
The faulty locking piece may not provide sufficient force to lock the instrument carrier to the Arc system. This could cause the carrier to become dislodged during use, potentially leading to injury if the instrument is not properly secured.
Healthcare professionals using the Leksell Vantage Stereotactic System for neurological procedures are most at risk. The affected units have specific serial numbers listed in the recall notice.
Check if your Leksell Vantage Stereotactic System Instrument Carrier has serial numbers SH00106 to SH00178. The unique device identifier (UDI) is 7340048304887.
Verify your instrument carrier's serial number is listed in the recall (SH00106 to SH00178).
Reach out to Elekta for further instructions on how to address the issue.
The Leksell Vantage Stereotactic System Instrument Carrier (part of the Leksell Vantage Arc) with serial numbers SH00106 to SH00178.
Check if your instrument carrier has a serial number in the range SH00106 to SH00178. The unique device identifier (UDI) is 7340048304887.
Contact Elekta directly for instructions on how to address the issue, as the recall does not specify a replacement or repair.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1826-2020 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1826-2020 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.
