Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.. Recall Number Z-1098-2017 REASON Software error. Potential for...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management,...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Cobas b 123 POC systemThe cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives...Read More

Company: Roche Diabetes Care, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App Recall Number Z-1099-2017 REASON iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure Recall Number Z-1091-2017 REASON There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does...Read More