CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Merge PACS recalled by Merge Healthcare

Merge Healthcare is recalling Merge PACS, distributed in 17 states. The recall was initiated on 4 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 7.0.1

Quantity recalled29 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-1176-2017
FDA event ID: 76260
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2016
FDA classified: 9 Feb 2017
Reported: 15 Feb 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: Medical Software

Timeline

4 Apr 2016	Recall initiated by company
9 Feb 2017	Classified by FDA	+311 days
15 Feb 2017	Published in enforcement report	+6 days

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

Reason for recall

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Where it was distributed

Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.

Arizona California Colorado Florida Hawaii Illinois Massachusetts Maryland Michigan Missouri New York Ohio Pennsylvania South Carolina Tennessee Utah Wisconsin

Questions about this recall

Is Merge PACS recalled?

Yes. Merge Healthcare recalled Merge PACS on 4 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1176-2017.

Why was it recalled?

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

Which lots are affected?

Version 7.0.1

Where was it sold?

Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military 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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