29
Mar
2017

Cl II Merge Cardio software.

0

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

PRODUCT

Merge Cardio software..
Recall Number Z-1486-2017

REASON
Cardio study list does not show STAT studies without refreshing.

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

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

DISTRIBUTION
USA (nationwide ) Distribution to medical facilities. Military distribution was also made. There was no foreign/government distribution.

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About the author

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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