Merge Healthcare recalls medical imaging workstations with software version V9.5 for inaccurate measurements. Affected units may display incorrect diagnostic data.
“Merge PACS Workstation Software Inaccurate Measurements - Recall.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697853-merge-pacs-workstation-software-inaccurate-measurements-recall. Based on FDA recall #Z-3004-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3004-2026%22&limit=1).
The FDA announced on July 22, 2026, that Merge Healthcare, Inc. is recalling Merge PACS and Merge OrthoPACS medical imaging diagnostic workstations due to a software issue that may cause measurements to be displayed inaccurately.
How to tell if you have it
Brand: Merge Healthcare
Product: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
The software issue may cause measurements to be displayed inaccurately, according to the FDA.
Context
GovInfoNow's records show Merge Healthcare, Inc. has 11 other recalls on record since June 13, 2017. Other recent recalls of similar products include GE Healthcare Centricity PACS Software Recall (July 31, 2026), FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026), and GE Healthcare Centricity PACS Server V7 Recall (July 31, 2026).
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
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
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.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Kentucky, Nebraska, Washington.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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.
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.