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

Merge Cardio recalled by Merge Healthcare

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

Check your package

Lot, batch or date codesVersions 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, 9.0.9, and 10.0.

Quantity recalled110 sites potentially have 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-1403-2017
FDA event ID: 76590
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2016
FDA classified: 3 Mar 2017
Reported: 15 Mar 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
3 Mar 2017	Classified by FDA	+333 days
15 Mar 2017	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

When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

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.

Where it was distributed

Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Nationwide

Questions about this recall

Is Merge Cardio recalled?

Yes. Merge Healthcare recalled Merge Cardio on 4 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1403-2017.

Why was it recalled?

When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

Which lots are affected?

Versions 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, 9.0.9, and 10.0.

Where was it sold?

Distribution was made to medical facilities nationwide. There was no foreign/military/government 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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