{"url_path":"/fda/device/recalls/Z-2006-2026","section_key":"summary","section_title":"DEVICE Recall: Elekta, Inc. — Brand Name: Leksell Vantage Arc System  REF: 1053958","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Elekta, Inc."},"word_count":169,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2006-2026\n\n**Recalling firm:** Elekta, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-19\n**Report date:** 2026-05-06\n\n## Product\nBrand Name: Leksell Vantage Arc System  REF: 1053958\n\n## Reason\nLocking mechanisms  may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.\n\n## Affected lots\nLot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675\n\n## Distribution\nUS: AR\tAZ\tCA\tCO\tDC\tFL\tGA\tID\tIL\tKS\tMA\tMD\tME\tMO\tMT\tNC\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tPA\tSC\tTX\tUT\tVA\tWA\tWI\tWV   OUS: Algeria\tAustralia\tAustria\tAzerbaijan\tBelgium\tChina\tColombia\tCosta Rica\tCroatia\tCzech Republic\tEgypt\tEstonia\tFinland\tFrance\tGermany\tGreece\tHong Kong\tHungary\tIndia\tIsrael\tItaly\tJapan\tKorea, Republic of\tKuwait\tLithuania\tMexico\tMorocco\tNetherlands\tNew Zealand\tNorway\tPakistan\tPanama\tPoland\tPortugal\tSaudi Arabia\tSingapore\tSlovenia\tSouth Africa\tSpain\tSweden\tSwitzerland\tTaiwan\tTurkey\tUnited Kingdom"}