Company: Philips Healthcare (Suzhou) Co., Ltd. Date of Enforcement Report: 1/5/2024 Class II PRODUCT Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Recall Number: Z-0640-2024 REASON: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan....Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 1/5/2024 Class II PRODUCT Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus....Read More