Merge Healthcare, Inc. recalls Merge OrthoPACS

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Merge OrthoPACS, medical imaging diagnostic workstation

Merge Healthcare issued an Urgent Field Safety Notice (Revision 2) to its consignees on 6/30/2026 via email. The notice explained the issue and when it may occur, risk to patient, and requested an immediate workaround, a configuration change, be performed to disable automatic refresh of the Thumbnail Bar until a software update is available. The notice also directions the consignee to forward the notice to any individuals within their organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The notice was followed by telephone calls beginning on 7/6/2026 to ensure the notice was received. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge.

• FDA enforcement recordOfficial FDA database entry for Z-2875-2026
• FDA 510(k) clearance · K192455The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Merge Healthcare, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.