Company: Diagnos Inc. Date of Enforcement Report: 4/6/2022 Class II PRODUCT CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall Number: Z-0826-2022 REASON Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. RECALLING FIRM/MANUFACTURER Diagnos Inc....Read More

Company: InfuTronix LLC Date of Enforcement Report: 4/6/2022 Class II PRODUCT Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Recall Number: Z-0832-2022 REASON An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/6/2022 Class II PRODUCT Ysio system with VC10 software version, Model Number 10281013. Radiographic system Recall Number: Z-0841-2022 REASON Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for...Read More