Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Stratus CS STAT Fluorometric Analyzer-microproc essor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 Recall Number Z-2525-2016 REASON Software defect, where either an Above...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. Recall Number Z-2380-2016 REASON Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical Systems,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. Recall Number Z-2346-2016 REASON The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. Recall Number Z-2347-2016 REASON The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Model No. 728323; To produce cross-sectional images of the body. Recall Number Z-2384-2016 REASON Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. Recall Number Z-2383-2016 REASON Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray systems X-ray systems is 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-2371-2016 REASON Software defect causing intermittently slow response of Host....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body. Recall Number Z-2381-2016 REASON Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. Recall Number Z-2382-2016 REASON Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance CT 16 Power Computed Tomography X-ray systems X-ray systems is 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-2370-2016 REASON Software defect causing intermittently slow response...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray systems is 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-2366-2016 REASON Software defect causing intermittently slow response of Host. RECALLING FIRM/MANUFACTURER...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 16 Computed Tomography X-ray systems X-ray systems is 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-2369-2016 REASON Software defect causing intermittently slow response of Host....Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2363-2016 REASON When measuring a lesion on an...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. Recall Number Z-2379-2016 REASON The patient name in the Halo title bar and the thumbnails do not match the name on...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance BigBore Oncology Computed Tomography X-ray systems is 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-2367-2016 REASON Software defect causing intermittently slow response of Host. RECALLING...Read More