Company: Konica Medical Imaging, Inc,Date of Enforcement Report: 8/24/05 Class: III PRODUCT Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05 REASON One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three...Read More

Company: CepheidDate of Enforcement Report: 8/24/05 Class: II PRODUCT SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05 REASON A problem in the software has the potential to be associated with the incorrect reporting of sample results. CODE All units with software code version numbers: PN950-0101, Rev 1.7...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 8/24/05 Class: II PRODUCT Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05 REASON Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results. CODE Versions...Read More