CLASS II Device recall · Reported 5 Jul 2017 · 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 15 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4

Quantity recalled638 sites have the potentially 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-2628-2017
FDA event ID: 77299
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2016
FDA classified: 23 Jun 2017
Reported: 5 Jul 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

15 Apr 2016	Recall initiated by company
23 Jun 2017	Classified by FDA	+434 days
5 Jul 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

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

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. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.

Where it was distributed

Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.

Nationwide

Questions about this recall

Is Merge LIS recalled?

Yes. Merge Healthcare recalled Merge LIS on 15 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2628-2017.

Why was it recalled?

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

Which lots are affected?

Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4

Where was it sold?

Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no 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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