Company: Stryker Endoscopy Date of Enforcement Report 9/17/2008 Class:ll PRODUCT Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, Recall # Z-1316-2008 REASON Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/17/2008 Class:lll PRODUCT a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202; Recall...Read More

Company: MIMvista Corp Date of Enforcement Report 9/17/2008 Class:ll PRODUCT MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP; Recall # Z-1827-2008 REASON In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 9/17/2008 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; Recall # Z-1826-2008 REASON A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis. RECALLING FIRM/MANUFACTURER...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 9/17/2008 Class:ll PRODUCT GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; Recall # Z-1825-2008 REASON Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or...Read More

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