medical Class II Updated 2020-05-06

Elekta Inc recalls Leksell Vantage Stereotactic System. Instrument Carrier, Par

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.

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