Product Wiki · Recalls · U.S. FDA — Device Enforcement

Leksell Vantage Stereotactic System — recall Z-1826-2020

U.S. FDA — Device Enforcement · United States · 2020-03-30 · Class II

As described by U.S. FDA — Device Enforcement: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1826-2020
Date of alert
2020-03-30
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Elekta Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
Barcode (EAN/GTIN)
7340048304887
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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