Company: Medtronic Navigation, Inc Date of Enforcement Report:12/26/2007 Class:lll PRODUCT Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 – April 4, 1999 to April 24, 2007...Read More

Company: Data Innovations, Inc., Date of Enforcement Report:12/26/2007 Class:ll PRODUCT Data Innovations Instrument Manager Software versions 7.04.0001 through 8.04.03.01, Recall # B-0195-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South Burlington, VT, by e-mail on September 19, 2007 and by follow-up letter dated October 11, 2007. Firm initiated...Read More