Company:Philips Medical Systems, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-1056-2012 REASON A number of non-conformances have been noted...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT Siemens syngo Imaging XS. Radiological image processing system. Model number 10496279. Recall # Z-1064-2012 REASON Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using...Read More

Company:Microsoft Amalga Date of Enforcement Report 3/14/12 Class ll: PRODUCT Microsoft Amalga – previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 Product Usage: Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or...Read More

Company:Boston Scientific CRM Corp Date of Enforcement Report 3/14/12 Class lll: PRODUCT LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1096-2012 REASON Patients are not able to perform setup. There...Read More

Company:Philips Medical Systems, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT 1) Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer. Syngo RT Therapist v4.1, part number 8162815; Syngo RT Therapist Assist (off line system),...Read More