Company: Mobius Medical Systems, LP Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially...Read More

Company: Magellan Diagnostics Inc. Date of Enforcement Report: 5/24/2017 Class I: PRODUCT Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results. The LeadCare Plus and the LeadCare Ultra Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a...Read More

Company: Ion Beam Applications S.A .Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Proton therapy system -Proteus 235 aka Proteus Plus. 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. Recall Number Z-2097-2017 REASON A PBS (Pencil...Read More

Company: Ortho-Clinical Diagnostics. Date of Enforcement Report 5/24/2017 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD Recall Number Z-2077-2017 REASON Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the...Read More