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
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