Sep

2016

Merge Cardio software. Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/7/2016
Class lI:

PRODUCT

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Recall Number Z-2709-2016

REASON
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR)..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
116 customers potentially have the affected versions

DISTRIBUTION
US Distribution to: CO and OK.

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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 Cardio software. Cl II

Amy Sellers

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