Company: Elekta, Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0557-2016 REASON Incorrect drug dosage...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. Recall Number Z-0554-2016 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 1/6/2016 Class lI: PRODUCT Merge Cardio with software version 10.1 LA. Recall Number Z-0555-20166 REASON The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. RECALLING FIRM/MANUFACTURER Merge Healthcare Inc., Hartland, WI...Read More