VUAB Pharma a.s..Product: pharmaceutical manufacturing facility Date: 5/27/2015 ailure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions. Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of (b)(4), API. Specifically, our inspection revealed your firm did not...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DuraDiagnost X- Ray Recall Number Z-1555-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DigitalDiagnost System X-Ray Recall Number Z-1554-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591...Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1)...Read More

Company: Baxter Corporation Englewood Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. Recall Number Z-1628-2015 REASON Baxter Corporation is conducting a field action for...Read More