Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Linear accelerator workstation software suite. Recall # Z-1084-04. REASON An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1. CODE MLC Workstation...Read More

Company: Siemens Medical Solutions USADate of Enforcement Report: 7/21/04 Class: II PRODUCT Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04. REASON The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR...Read More

Company: Fischer Imaging CorpDate of Enforcement Report: 7/21/04 Class: II PRODUCT Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04. REASON Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. CODE Product number 94829G-1, 94830G-1, 94830G-2. RECALLING FIRM/MANUFACTURER Fischer Imaging Corp, Denver, CO, by...Read More

Company: Adac LabsDate of Enforcement Report: 7/21/04 Class: III PRODUCT Emission Computed Tomography System. Recall # Z-1079-04. REASON Software problems may cause the detector head to drift unexpectedly. CODE Model number 2163-3000A, 2163-3000B; 510K K011611. RECALLING FIRM/MANUFACTURER Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing. VOLUME OF PRODUCT...Read More