Company:Medtronic Navigation, Inc Date of Enforcement Report 2/11/2009 Class:ll PRODUCT Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009 REASON Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 2/18/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) 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...Read More