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FDAFebruary 23, 2024device

RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

What to do

FDA enforcement status: Ongoing

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

073500020101290735000201020407350002010235073500020101740735000201048807350002010266073500020102970735000201030307350002010365073500020106550735000201031007350002010471

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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