CLASS II Device recall · Reported 20 Jul 2016 · FDA Enforcement Report

Merge OfficePACS recalled by Merge Healthcare

Merge Healthcare is recalling Merge OfficePACS, distributed in 23 states. The recall was initiated on 31 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 3.4

Quantity recalled49 sites 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-2159-2016
FDA event ID: 74510
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2016
FDA classified: 11 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

31 Jan 2016	Recall initiated by company
11 Jul 2016	Classified by FDA	+162 days
20 Jul 2016	Published in enforcement report	+9 days

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

Reason for recall

Potential data loss occurs as a result of product archiving not working properly.

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 OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

Where it was distributed

Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.

Alabama Arizona California Colorado Connecticut Florida Georgia Idaho Illinois Kentucky Massachusetts Missouri North Carolina Nebraska New Hampshire New Jersey New York Oklahoma Pennsylvania South Carolina

Questions about this recall

Is Merge OfficePACS recalled?

Yes. Merge Healthcare recalled Merge OfficePACS on 31 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-2159-2016.

Why was it recalled?

Potential data loss occurs as a result of product archiving not working properly.

Which lots are affected?

Version 3.4

Where was it sold?

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.

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

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide