FDA-Device2020-05-06Class II
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Elekta Inc
Hazard
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.
Sold states
US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
Affected count
25 units.
Manufactured in
1450 Beale St Ste 205, N/A, Saint Charles, MO, United States
Products
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1826-2020Don't want to check this manually?
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