Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Core Computed Tomograph X-ray Systems, Product Usage: 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-1873-2016 REASON The firm became aware of a problem where the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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-1872-2016 REASON The firm became aware of a problem where the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray Systems, Product Usage: 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-1874-2016 REASON The firm became aware of a problem where...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/8/2016 Class lI: PRODUCT Ingenuity Computed Tomography X-ray Systems, Product Usage: 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-1875-2016 REASON The firm became aware of a problem where the system...Read More