Company: SCC Soft Computer Date of Enforcement Report:12/18/2013 Class lI: PRODUCT SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Recall Number B-0216-14 REASON Blood Bank software with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwataer, FL on 11/11//2013. Voluntary: Firm Initiated...Read More

Company: Omnyx Llc Date of Enforcement Report:12/18/2013 Class lI: PRODUCT Digital Pathology System (DPS) Software version 1.1 The Omnyx” Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx” products are for...Read More

Company: Iba Dosimetry Gmbh Date of Enforcement Report:12/18/2013 Class lI: PRODUCT iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014 REASON The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation....Read More

Company: GE Healthcare LLC Date of Enforcement Report: 12/18/2013 Class lI: PRODUCT GE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters...Read More