CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Merge Hemo recalled by Merge Healthcare

Merge Healthcare is recalling Merge Hemo, 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 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.

Quantity recalled24 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-1778-2017
FDA event ID: 76859
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2016
FDA classified: 11 Apr 2017
Reported: 19 Apr 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: Heart & Vascular Devices

Timeline

4 Apr 2016	Recall initiated by company
11 Apr 2017	Classified by FDA	+372 days
19 Apr 2017	Published in enforcement report	+8 days

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

Reason for recall

Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

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 Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Where it was distributed

Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.

Nationwide Arizona California Colorado Florida Georgia Kansas Louisiana Michigan Missouri Ohio Oklahoma Tennessee Texas Virginia Washington Wisconsin West Virginia

Questions about this recall

Is Merge Hemo recalled?

Yes. Merge Healthcare recalled Merge Hemo on 4 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1778-2017.

Why was it recalled?

Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

Which lots are affected?

Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.

Where was it sold?

Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.

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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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide