Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0. Recall Number Z-0821-2015 REASON Software Anomaly; Because of a software bug, the VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. Recall Number Z-0818-2015 REASON When using the...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products. Recall Number Z-0815-2015 REASON When using the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d)...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging. Recall Number Z-0817-2015...Read More

Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging. Recall Number Z-0816-2015...Read More

Company: Carestream Health, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Recall Number Z-0820-2015 REASON Reduced mammographic image quality when attempting to print true size multi-format images RECALLING FIRM/MANUFACTURER Carestream Health, Inc., Rochester, NY on...Read More