Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report 4/20/2016 Class lI: PRODUCT SurgiCounter” scanner Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures. Recall Number Z-1379-2016 REASON The affected SurgiCounter scanner...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray Systems, 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-1356-2016 REASON The firm was notified of a software error in which the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray Systems, 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-1354-2016 REASON The firm was notified of a software error in which the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray Systems, 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-1355-2016 REASON The firm was notified of a software error in which...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance iCT:Computed Tomography X-ray Systems, 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-1352-2016 REASON The firm was notified of a software error in which the system...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance iCT:SP Computed Tomography X-ray Systems, 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-1353-2016 REASON The firm was notified of a software error in which the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/202016 Class lI: PRODUCT Brilliance 64:Computed Tomography X-ray Systems, 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-1351-2016 REASON The firm was notified of a software error in which the system...Read More

Company: Alcon Research, Ltd.Date of Enforcement Report 4/20/2016 Class lI: PRODUCT VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the...Read More