Company Velocity Medical Solutions, LLC.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume...Read More

Company Spacelabs Healthcare, Llc.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. Recall Number Z-1273-201 REASON Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs...Read More

Company Bio-Rad Laboratories, Inc.Date of Enforcement Report:4/2/2014 Class lI: PRODUCT D-10″ Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution,...Read More