CLASS II Device recall · Reported 28 Jun 2017 · FDA Enforcement Report

Merge OrthoPACS recalled by Merge Healthcare

Merge Healthcare is recalling Merge OrthoPACS, distributed nationwide in the US. The recall was initiated on 24 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 6.6, 6.6.1, and 6.6.2

Quantity recalled98 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-2620-2017
FDA event ID: 77265
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2017
FDA classified: 22 Jun 2017
Reported: 28 Jun 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

24 May 2017	Recall initiated by company
22 Jun 2017	Classified by FDA	+29 days
28 Jun 2017	Published in enforcement report	+6 days

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

Reason for recall

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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 OrthoPACS software.

Where it was distributed

Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

Nationwide

Questions about this recall

Is Merge OrthoPACS recalled?

Yes. Merge Healthcare recalled Merge OrthoPACS on 24 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2620-2017.

Why was it recalled?

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

Which lots are affected?

Versions 6.6, 6.6.1, and 6.6.2

Where was it sold?

Distribution was made nationwide to medical facilities. There was no foreign/government/military 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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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
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12 Aug 2026Device	CLASS II	Merge PACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
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