Merge PACS 9.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000101239), received between Jul 21, 2026 and Jul 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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. Jul 22, 2026Open, Classified

   Software issue may cause measurements to be displayed inaccurately.

   Z-3004-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894797 ↗

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-2874-2026 · Jun 30, 2026 · Open, Classified
  Merge PACS, 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