FDA-Device2024-04-17Class II
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
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.
Sold states
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.
Affected count
154 units
Manufactured in
Eugeniavagen 18c, N/A, Stockholm, N/A, Sweden
Products
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1482-2024Don't want to check this manually?
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