CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Merge Eye Station recalled by Merge Healthcare

Merge Healthcare is recalling Merge Eye Station, distributed nationwide in the US. The recall was initiated on 9 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes136 T1700 Capture Stations 46 T5810 Capture Stations

Quantity recalled182 capture stations

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-1142-2017
FDA event ID: 75149
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 9 Dec 2016
FDA classified: 6 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

9 Dec 2016	Recall initiated by company
6 Feb 2017	Classified by FDA	+59 days
15 Feb 2017	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

Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.

Product as listed by the FDA

Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

Where it was distributed

Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.

Nationwide California Colorado Connecticut Florida Hawaii Illinois Indiana Louisiana Massachusetts Maryland Minnesota Mississippi North Carolina North Dakota New York Ohio Oklahoma Oregon Pennsylvania Rhode Island

Questions about this recall

Is Merge Eye Station recalled?

Yes. Merge Healthcare recalled Merge Eye Station on 9 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1142-2017.

Why was it recalled?

Which lots are affected?

136 T1700 Capture Stations 46 T5810 Capture Stations

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

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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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26 Mar 2025Device	CLASS II	Vericis, Merge Cardio recalled by Merge Healthcare	Merge Healthcare	Device Malfunction	WI

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