The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a...Read More

Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into...Read More

Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a...Read More

Company:Datascope Corp./MAQUET. Date of Enforcement Report 9/6/2017 Class II: PRODUCT Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices: Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure...Read More