Jan

2017

Merge Eye Station Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 1/11/2017
Class lI:

PRODUCT

Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
Recall Number Z-1017-2017

REASON
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 12/9/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1597 (1451 US; 146 OUS)

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Merge Eye Station Cl II

Amy Sellers

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