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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K220141
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Product Description
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Recall
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FDA Recall
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RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.... 2 09/02/2025 RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Num... 2 02/19/2025 RAYSEARCH LABORATORIES AB
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Pl... 2 05/01/2024 RAYSEARCH LABORATORIES AB
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B,... 2 04/05/2024 RAYSEARCH LABORATORIES AB
RayStation 11B 2 06/28/2022 RAYSEARCH LABORATORIES AB
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