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Recall Observatory FDA recall evidence

Device product

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

Z-1826-2020

March 30, 2020

Class II

Product summary

Firm
Elekta Inc
Event
Event 85352
Status
Terminated
Classification
Class II
Quantity
25 units.
Official record key
device-enforcement:Z-1826-2020

Official wording

Reason: 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.

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.