Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 7/12/2017 Class lI: PRODUCT Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 — Programmable diagnostic computer, Recall Number Z-2688-2017 REASON Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/...Read More

Company: Ion Beam Applications S.A.. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System – Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation....Read More

Company: CardioTek BV. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. Recall Number Z-2657-2017 REASON Software bug which allows parameters to be changed unintentionally...Read More

Company:CareFusion 303, Inc. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Alaris PC Unit, Model 8015 Recall Number Z-2671-2017 REASON BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. RECALLING...Read More