Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Ingenuity TF PET/CT (model 882442) running software version 4.0.2This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission...Read More

Company:Roche Diabetes Care, Inc. Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Recall Number Z-0625-2018 REASON Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a...Read More