Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 11/13/2013 Class lI: PRODUCT Siemens RAD Fluoro Uro Systems – Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems Recall Number Z-0016-2014 REASON Siemens has discovered through product monitoring a potential malfunction when using system operating with software...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/13/2013 Class lI: PRODUCT COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of...Read More

Company: Carestream Health Inc. Date of Enforcement Report: 11/13/2013 Class lI: PRODUCT DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients Recall Number Z-0179-2014 REASON Carestream Health Inc. has conducted a voluntary...Read More