CompanyVital Images, Inc. .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety...Read More

Company:Biomerieux Inc .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700...Read More

Company:Toshiba American Medical Systems Inc .Date of Enforcement Report4/3/2013 Class ll: PRODUCT Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Recall Number Z-0994-2013 REASON Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Recall Number Z-0997-2013 REASON The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under...Read More