CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Merge Cardio recalled by Merge Healthcare

Merge Healthcare is recalling Merge Cardio, distributed in 8 states. The recall was initiated on 22 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Quantity recalled16 sites were originally identified as potentially having the affected 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-1496-2017
FDA event ID: 76717
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 22 Sep 2015
FDA classified: 20 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

22 Sep 2015	Recall initiated by company
20 Mar 2017	Classified by FDA	+545 days
29 Mar 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

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

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 with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Where it was distributed

US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.

Georgia Illinois Maryland Michigan Missouri Ohio Tennessee Vermont

Questions about this recall

Is Merge Cardio recalled?

Yes. Merge Healthcare recalled Merge Cardio on 22 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-1496-2017.

Why was it recalled?

Which lots are affected?

Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Where was it sold?

US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. 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.

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