Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers – 10863171, 10863172, 10863173, Recall Number Z-2088-2016 REASON Software error in previous software versions in which two references for the same image may exist in the database. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets., Recall Number Z-2107-2016 REASON Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior:...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-2117-2016 REASON Philips Healthcare received...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes…...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes...Read More

Company: CareFusion 303 Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. Recall Number Z-2064-2016 REASON A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore...Read More