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FDA · Medical devices ·

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation recall

Merge Healthcare, Inc. recalled Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation on September 2, 2026 because of software issue may cause measurements to be displayed inaccurately. It was sold nationwide.

Why it was recalled

Software issue may cause measurements to be displayed inaccurately.

What's recalled

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Quantity: 20 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Merge Healthcare, Inc., Hartland, WI
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Status
Ongoing
Recall number
Z-3004-2026
Source
U.S. Food and Drug Administration

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