Merge PACS Workstation Software Inaccurate Measurements - Recall

✎ GovInfoNow plain-language explainer

What happened, in plain English

Merge Healthcare is recalling medical imaging diagnostic workstations that use software version V9.5. This software issue could cause measurements to be displayed inaccurately, potentially affecting diagnostic accuracy.

Why it’s dangerous

The software issue causes measurements to be displayed inaccurately. This could lead to incorrect diagnostic interpretations if the system is used for critical medical imaging tasks.

Who’s affected

Medical facilities using Merge PACS or Merge OrthoPACS workstations with software version V9.5 are affected. Staff and patients using these systems may be at risk of inaccurate diagnostic measurements.

How to tell if you have this one

Check for software version V9.5 on your Merge PAC: 'V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409' in the system's software information.

Brand
Merge Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version matches 'V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409' to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall addresses a software issue that may cause inaccurate measurements, but it does not pose a risk of injury or serious harm. The hazard level is low risk.

How do I know if my system is affected?

Check your system's software version for 'V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409' to confirm if it's affected.

What should I do if my system is affected?

The recall does not specify a remedy, so you should check with Merge Healthcare for guidance on potential software updates or corrections.

Take action

Contact Merge Healthcare

We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-3004-2026 — Merge Healthcare Merge Healthcare

Hello,

I own a Merge Healthcare that is covered by recall Z-3004-2026 from Merge Healthcare.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3004-2026 (July 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3004-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Lower-risk recall