10
Aug
2016

Cl II Merge PACS software

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/10/2016
Class lI:

PRODUCT

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Recall Number Z-2301-2016

REASON
Studies coming over via telmed were missing patient’s DOB, procedure, and referring physician.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. Hartland, WI on 1/30/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
109 sites

DISTRIBUTION
USA, New Zealand, and United Kingdom.

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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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