Day

July 3, 2023
03
Jul

FDA Recall: Software Bug Could Lead to More Liberal Plan Than Needed

July 3, 2023
Company: RaySearch America Inc Date of Enforcement Report: 07/03/2023 Class II PRODUCT Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Recall Number: Z-2039-2023 REASON: A software bug affecting results when...
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03
Jul

Software CAPA

July 3, 2023
#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?
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