CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Merge LIS recalled by Merge Healthcare

Merge Healthcare is recalling Merge LIS, distributed nationwide in the US. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions: 4.0.1 and earlier.

Quantity recalled413 sites potentially have the affected software

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-0399-2017
FDA event ID: 75419
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2015
FDA classified: 11 Nov 2016
Reported: 23 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Medical Software

Timeline

5 Mar 2015	Recall initiated by company
11 Nov 2016	Classified by FDA	+617 days
23 Nov 2016	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

There is a potential for duplicate container numbers to be created for patients.

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 LIS software.

Where it was distributed

Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.

Nationwide

Questions about this recall

Is Merge LIS recalled?

Yes. Merge Healthcare recalled Merge LIS on 5 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-0399-2017.

Why was it recalled?

There is a potential for duplicate container numbers to be created for patients.

Which lots are affected?

Versions: 4.0.1 and earlier.

Where was it sold?

Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.

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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