CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report

Merge Cardio recalled by Merge Healthcare

Merge Healthcare is recalling Merge Cardio, distributed in 14 states. The recall was initiated on 13 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Quantity recalled30 sites have the potentially affected software versions

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-2123-2017
FDA event ID: 77124
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2016
FDA classified: 22 May 2017
Reported: 31 May 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

13 Apr 2016	Recall initiated by company
22 May 2017	Classified by FDA	+404 days
31 May 2017	Published in enforcement report	+9 days

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

Reason for recall

Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.

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 Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

Where it was distributed

Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

Arizona Connecticut Florida Georgia Illinois Indiana Louisiana Michigan North Carolina New York Ohio Oklahoma Texas Vermont

Questions about this recall

Is Merge Cardio recalled?

Yes. Merge Healthcare recalled Merge Cardio on 13 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2123-2017.

Why was it recalled?

Which lots are affected?

Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

Where was it sold?

Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

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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