Company: Merge Healthcare, Inc. Date of Enforcement Report: 8/21/2026 Class: II PRODUCT: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Recall Number: Z-3004-2026 REASON: Software issue may cause measurements to be displayed inaccurately. RECALLING FIRM/MANUFACTURER: Merge Healthcare, Inc. VOLUME: 20 units DISTRIBUTION: US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.Read More

SoftwareCPR Instructors! Our General Manager and Partner, Brian Pate, will be teaching an upcoming (October 27-29, 2026) Association for the Advancement of Medical Instrumentation (AAMI) course on medical device software validation. What is the AAMI course on medical device software validation? AAMI’s course on Medical Device Software Validation covers FDA, EU MDR, cybersecurity, cloud computing,...Read More