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, 6.6.2, 6.6.2.1, and 6.6.2.2

Quantity recalled160 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-2601-2017
FDA event ID: 77271
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2017
FDA classified: 16 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
16 Jun 2017	Classified by FDA	+23 days
28 Jun 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

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

Which lots are affected?

Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2

Where was it sold?

USA (nationwide) Distribution was made 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 26 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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