Merge PACS 9.4Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K192455); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 30, 2026Open, Classified

   Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

   Z-2874-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192455. One submission often covers many models, so check the product and lot details in each record.

• Z-3004-2026 · Jul 22, 2026 · Open, Classified
  Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
• Z-2875-2026 · Jun 30, 2026 · Open, Classified
  Merge OrthoPACS, medical imaging diagnostic workstation
• Z-2944-2020 · Aug 6, 2020 · Terminated
  Merge PACS