Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as...Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company: Beckman Coulter Inc..Date of Enforcement Report 12/23/2015 Class lI: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-ray system Recall Number Z-0408-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-ray system Recall Number Z-0406-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0407-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 12/23/2015 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-ray system Recall Number Z-0405-2016 REASON During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan....Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR...Read More

Company: GE Medical Systems, LLC.Date of Enforcement Report 12/23/2015 Class lI: PRODUCT GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table,...Read More

Cadila Healthcare Limited.Product: pharmaceutical manufacturing facilities Date: 12/23/2015 Our investigators observed specific violations during the inspection, including, but not limited to the following. Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. a. Your firm failed to adequately control the use of computerized systems in the...Read More