Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT 1) iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system...Read More

Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT AExtended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace?? (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of...Read More

Company: Ortho-Clinical Diagnostics.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011 REASON Software defect problem is repeatable.. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning...Read More

Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Extended Brilliance Workstation (EBW) a component of the Computed Tomography The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; Model #728231. Recall...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT 1) ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 &...Read More