CLASS II Device recall · Reported 13 Sep 2017 · FDA Enforcement Report

Merge Unity recalled by Merge Healthcare

Merge Healthcare is recalling Merge Unity, distributed nationwide in the US. The recall was initiated on 14 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.

Quantity recalled98 sites have the potentially affected software

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3105-2017
FDA event ID: 77811
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 14 Aug 2017
FDA classified: 5 Sep 2017
Reported: 13 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

14 Aug 2017	Recall initiated by company
5 Sep 2017	Classified by FDA	+22 days
13 Sep 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

Which lots are affected?

Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Merge Healthcare

All 96

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
12 Aug 2026Device	CLASS II	Merge OrthoPACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
12 Aug 2026Device	CLASS II	Merge PACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
10 Sep 2025Device	CLASS II	The Merge Hemo recalled by Merge Healthcare	Merge Healthcare	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Vericis, Merge Cardio recalled by Merge Healthcare	Merge Healthcare	Device Malfunction	WI

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide