Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; : Intended to produce cross-sectional images of the body. Recall Number Z-1521-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Recall Number Z-1518-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition Flash: Intended to produce cross-sectional images of the body. Recall Number Z-1520-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/27/2016 Class lI: PRODUCT Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Recall Number Z-1519-2016 REASON Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 4/13/2016 Class lI: PRODUCT ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories Recall Number Z-1500-2016 REASON TSoftware anomaly; Siemens identified that software version 1.4.2133 on...Read More