Use cautionMedical device recall · FDA · Published March 30, 2020
Elekta Leksell Vantage Stereotactic System Recall: Faulty Locking Piece Risk
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.
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Contact the company
📍Recalling firmElekta Inc1450 Beale St Ste 205 · Saint Charles, MO 63303
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/65593-elekta-leksell-vantage-stereotactic-system-recall-faulty-locking-piece-risk.
“Elekta Leksell Vantage Stereotactic System Recall: Faulty Locking Piece Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65593-elekta-leksell-vantage-stereotactic-system-recall-faulty-locking-piece-risk. Based on FDA recall #Z-1826-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1826-2020%22&limit=1).
The FDA announced on 2020-03-30 that Elekta Inc. is recalling the Leksell Vantage Stereotactic System Instrument Carrier due to a faulty locking piece that may not meet locking force requirements. The agency classified this as a Class II recall.
How to tell if you have it
Brand: Elekta
Product: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958)
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.
Context
GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since 2017-06-19. Other recent recalls include the 2026-05-21 Elekta MOSAIQ Oncology System Software Recall and the 2026-04-03 Elekta Fletcher CT/MR Shielded Applicator Set Recall. Similar recent recalls of other products include the 2026-01-07 Philips Spectral CT Recall and the 2026-03-25 Olympus OER-ELITE Endoscope Reprocessor Tubes Recall.
How to tell if you have this one
Check if your Leksell Vantage Stereotactic System Instrument Carrier has serial numbers SH00106 to SH00178. The unique device identifier (UDI) is 7340048304887.
Brand
Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify your instrument carrier's serial number is listed in the recall (SH00106 to SH00178).
Contact Elekta
Reach out to Elekta for further instructions on how to address the issue.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Louisiana, Massachusetts, Minnesota, Montana, New Hampshire, New York, North Carolina, Ohio, Utah.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1826-2020 (March 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1826-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.