Company: Merge Healthcare, Inc. Date of Enforcement Report 1/11/2017 Class lI: PRODUCT Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior Recall Number Z-1017-2017 REASON This recall has been initiated due to an issue related to the potential accidental...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 1/11/2017 Class lI: PRODUCT DR Systems Unity PACS software, now known as Merge Unity PACS software. Recall Number Z-0939-2017 REASON The software fails to associate to the correct MG image if there are two images for the same view. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on...Read More