Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 10/2/2026 Class: II PRODUCT Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.); Recall Number: Z-0078-2027 REASON: Software issues...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 10/2/2026 Class: II PRODUCT DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 Recall Number: Z-0084-2027 REASON: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration...Read More

Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 10/2/2026 Class: II PRODUCT Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.); Recall Number: Z-0078-2027 REASON: Software issues...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 10/2/2026 Class: II PRODUCT DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252 Recall Number: Z-0083-2027 REASON: Beckman Coulter has identified...Read More