Company: Boston Scientific Corporation Date of Enforcement Report: 3/25/2020 Class II PRODUCT Boston Scientific, LATITUDE Programming System, Model 3300 – Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/25/2020 Class II PRODUCT Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and...Read More

Company: CME America, LLC Date of Enforcement Report: 3/25/2020 Class I PRODUCT CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG CV545, BG CV575, and CMExpress Recall Number: Z-1474-2020 REASON Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/25/2020 Class II PRODUCT Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. Recall Number: Z-1501-2020 REASON The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 3/25/2020 Class II PRODUCT Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. Recall Number: Z-1524-2020 REASON Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the...Read More