Day

December 20, 2023
20
Dec

FDA Recall: Software Problem Causing Erroneous Results

December 20, 2023
Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 12/20/2023 Class II PRODUCT epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11 Recall Number: Z-0601-2024 REASON: Siemens Healthcare...
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