Aug

2014

Cl II McKesson-Horizon Medical Imaging

Company: Mckesson Medical Immaging.
Date of Enforcement Report:8/5/2014
Class lI:

PRODUCT

Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-2121-2014

REASON
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

RECALLING FIRM/MANUFACTURER
Mckesson Medical Imaging, Richmond, BC on 5/5/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
659

DISTRIBUTION
Nationwide and Internationally

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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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Cl II McKesson-Horizon Medical Imaging

Amy Sellers

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