Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-2590-2017 REASON Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 Class lI: PRODUCT Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography Recall Number Z-2591-2017 REASON Merge PACS did not show unviewed images when the last...Read More