FDA Medical devices recall ·

Merge OrthoPACS, medical imaging diagnostic workstation recall

Recall number
Z-2875-2026
Date
(initiated June 30, 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
5 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Merge OrthoPACS, medical imaging diagnostic workstation

Why was it recalled?

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

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

UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, and UK.

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-2875-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.