Agency classClass IIOur severity:Severe FDA (Devices)·Z-2875-2026·Announced 2026-08-12

Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue

Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a medical imaging diagnostic workstation. Per the rubric, FDA Class II recalls with potential for temporary or medically reversible adverse health consequences are classified as Severe (score 4).

Plain-English summary

Merge Healthcare, Inc. is recalling 5 units of the Merge OrthoPACS medical imaging diagnostic workstation. The recall addresses a software issue in which thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

The affected versions are 9.4, 9.4 P01, and 9.4 P02, identified by UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302. The product is distributed worldwide, including US Nationwide and the countries of Canada and the UK.

This is an FDA Class II recall, meaning the device could cause temporary or medically reversible adverse health consequences if the issue leads to incorrect image review or diagnosis.

Healthcare facilities using the affected Merge OrthoPACS workstations should contact Merge Healthcare, Inc. for software updates or further instructions. Users should be aware of the potential for patient study mix-ups during image review.

The recalled product

Product: Merge OrthoPACS, medical imaging diagnostic workstation
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Medical Imaging Workstation
Hazard: mis-display
patient-data-confusion
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Merge Healthcare, Inc.

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Same hazard · mis display