Company: Siemens Medical Solutions, USA, Inc Date of Enforcement Report 5/7/2008 Class:ll PRODUCT a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0971-2008; b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0972-2008; c) Siemens...Read More

Company: Siemens Medical Solutions USA, Inc., Date of Enforcement Report 5/7/2008 Class:ll PRODUCT Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008 REASON Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 5/7/2008 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008 REASON Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [Read More

Company: Beckman Coulter, Inc Date of Enforcement Report 5/7/2008 Class:lll PRODUCT a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Recall # Z-0958-2008; b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number...Read More