Day

May 1, 2024
01
May

FDA Recall: Software Error May Lead to Reported SSD to be Too High

May 1, 2024
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/1/2-24 Class II PRODUCT RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System Recall Number: Z-1742-2024 REASON: Potential for reported SSD to be too high. RECALLING FIRM/MANUFACTURER: RAYSEARCH LABORATORIES AB VOLUME OF PRODUCT IN COMMERCE: 9 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries of Algeria,...
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