CLASS II Device recall · Reported 6 Jan 2016 · FDA Enforcement Report

Merge Hemo recalled by Merge Healthcare

Merge Healthcare is recalling Merge Hemo, distributed in Illinois, North Carolina, Vermont. The recall was initiated on 26 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMerge Hemo with software versions 10.0 LA

Quantity recalled2

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-0554-2016
FDA event ID: 72661
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 26 Oct 2015
FDA classified: 28 Dec 2015
Reported: 6 Jan 2016
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

26 Oct 2015	Recall initiated by company
28 Dec 2015	Classified by FDA	+63 days
6 Jan 2016	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

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

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 with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.

Where it was distributed

Distributed in the states of IL, NC, and VT.

Illinois North Carolina Vermont

Questions about this recall

Is Merge Hemo recalled?

Yes. Merge Healthcare recalled Merge Hemo on 26 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0554-2016.

Why was it recalled?

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

Which lots are affected?

Merge Hemo with software versions 10.0 LA

Where was it sold?

Distributed in the states of IL, NC, 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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