CLASS II Device recall · Reported 20 Jul 2016 · FDA Enforcement Report

Merge OfficePACS recalled by Merge Healthcare

Merge Healthcare is recalling Merge OfficePACS, distributed nationwide in the US. The recall was initiated on 30 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2

Quantity recalled216 sites have the 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-2144-2016
FDA event ID: 74522
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 30 Jan 2016
FDA classified: 8 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

30 Jan 2016	Recall initiated by company
8 Jul 2016	Classified by FDA	+160 days
20 Jul 2016	Published in enforcement report	+12 days

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

Reason for recall

Potential data loss occurs as a result of the software archiving not working properly.

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 OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Where it was distributed

The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.

Nationwide

Questions about this recall

Is Merge OfficePACS recalled?

Yes. Merge Healthcare recalled Merge OfficePACS on 30 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-2144-2016.

Why was it recalled?

Potential data loss occurs as a result of the software archiving not working properly.

Which lots are affected?

Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2

Where was it sold?

The software was distributed nationwide to medical facilities. There was no government/military/foreign 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 21 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

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