Jan

2016

Merge Cardio Cl II

Company: Merge Healthcare Inc.
Date of Enforcement Report 1/6/2016
Class lI:

PRODUCT

Merge Cardio with software version 10.1 LA.
Recall Number Z-0555-20166

REASON
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

RECALLING FIRM/MANUFACTURER
Merge Healthcare Inc., Hartland, WI on 10/26/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Distributed in the states of IL, NC, and VT.

___________________________________

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 Cardio Cl II

Amy Sellers

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