CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Merge OrthoCase recalled by Merge Healthcare

Merge Healthcare is recalling Merge OrthoCase, distributed in 15 states. The recall was initiated on 8 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

Quantity recalled30 sites potentially have the effected 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-0878-2017
FDA event ID: 75909
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 8 Oct 2015
FDA classified: 21 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Medical Software

Timeline

8 Oct 2015	Recall initiated by company
21 Dec 2016	Classified by FDA	+440 days
28 Dec 2016	Published in enforcement report	+7 days

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

Reason for recall

Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

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 OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

Where it was distributed

Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

California Colorado Connecticut Massachusetts Maryland Minnesota Montana Nebraska New Jersey Nevada New York Pennsylvania South Carolina Washington Wisconsin

Questions about this recall

Is Merge OrthoCase recalled?

Yes. Merge Healthcare recalled Merge OrthoCase on 8 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0878-2017.

Why was it recalled?

Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

Which lots are affected?

Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

Where was it sold?

Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

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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