Company: General Electric Med. Sys. Date of Enforcement Report:7/12/2006 Class:lIl PRODUCT Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system, Recall # Z-1172-06 REASON In the cardiac measurement section of the device the calculation of the...Read More

Company: Abbott Laboratories, Date of Enforcement Report:7/12/2006 Class:lIl PRODUCT ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3, Recall # Z-860-06 REASON The 30-day onboard storage information is not included in the...Read More