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Elekta Inc recalls Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic
Recalled May 6, 2020 · FDA recall Z-1826-2020 · Elekta
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. · FDA Class II
Units
25 units.
Sold at
US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
Description
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.
Product
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Manufacturer(s)
Elekta Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →