Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001. Recall Number: Z-0883-2021 REASON A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Recall Number: Z-0877-2021 REASON When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is...Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT Synapse PACS Software Versions 5.1 and higher Recall Number: Z-0878-2021 REASON There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies...Read More