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RAYSEARCH LABORATORIES AB recalls RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som
Recalled April 17, 2024 · FDA recall Z-1482-2024 · RAYSEARCH LABORATORIES AB
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. · FDA Class II
Units
154 units
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom.
Description
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Product
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →