Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 5/31/2017 Class lI: PRODUCT AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.. Recall Number Z-2156-2017 REASON An extremely dusty computer can cause problems at system start, or rarely, cause system fail....Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 5/31/2017 Class lI: PRODUCT Merge Cardio software Recall Number Z-2123-2017 REASON Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the wrong fetal measurements getting referenced. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc.,...Read More