Mar

2017

Merge Eye Station Import Utility Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Recall Number Z-1498-2017

REASON
System locks up which may result in potential patient injury or delay in diagnosis or treatment.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
78 sites potentially have the affected accessory

DISTRIBUTION
USA (nationwide ) Distribution to medical facilities. Government distribution was also made. Foreign distribution was made to Canada. There was no military distribution.

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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 Import Utility Cl II

Amy Sellers

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