Elekta Inc recalls Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxi…

Recall date

March 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1826-2020

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument