Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13 REASON ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary:...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT ngenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The...Read More

Company: One Lambda Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR Recall Number B-2326-13 REASON HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. RECALLING FIRM/MANUFACTURER One Lambda Inc., Canoga Park, CA...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare...Read More

Company: GE Healthcare It Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed...Read More

Company: Carestream Health, Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 — Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all...Read More