Company:Philips Ultrasound, Inc Date of Enforcement Report 3/4/2009 Class:ll PRODUCT a) Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. Recall # Z-0522-2009; b) Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System. Product also marketed...Read More

Company:GE Healthcare Integrated IT Solutions Date of Enforcement Report 3/4/2009 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 nurses....Read More