Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

Recall Insight

This FDA Devices action (record #Z-2379-2016) was formally reported on August 17, 2016, with the manufacturer initiating the action on January 30, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records indicate 93 sites have the affected version units are affected.

The documented reason for this recall is: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. Distribution data in the federal record shows the product reached: The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.