Company: TomoTherapy Incorporated. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Recall Number Z-0507-2015 REASON Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 12/17/2014 Class lI: PRODUCT Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0576-2015 REASON Printouts may be printed in incorrect...Read More

Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT MEVION S250, used for proton radiation therapy. Recall Number Z-0588-2015 REASON Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect...Read More

Company: INO Therapeutics (dba Ikaria). Date of Enforcement Report 12/17/2014 Class lI: PRODUCT INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units...Read More