FDA Medical devices recall ·
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation recall
- Recall number
- Z-3004-2026
- Date
- (initiated July 22, 2026)
- Company / brand
- Merge Healthcare, Inc.
900 Walnut Ridge Dr, Hartland, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Why was it recalled?
Software issue may cause measurements to be displayed inaccurately.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Distribution
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
States: California Florida Kentucky Nebraska Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3004-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.