Company: Heimann Systems CorporationProduct: Cabinet x-ray system Date: 10/30/2002 21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 10/30/02 Class: III PRODUCT Access 2 Immunoassay Systems — Systems Software Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3. REASON Erroneous result flags can result on printed reports and screen displays in rare circumstances. CODE Product Name: Access 2 Software Part Number: 973074 Lot Number Software Version...Read More