Oct

2013

Cl ll McKesson Horizon Medical Imaging

Company: Mckesson Information Solutions LLC
Date of Enforcement Report: 10/9/2013
Class ll:

PRODUCT

McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems. Recall Number Z-2318-2013

REASON
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

RECALLING FIRM/MANUFACTURER
Mckesson Information Solutions LLC, Alpharetta GA on 9/4/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
329 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

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 ll McKesson Horizon Medical Imaging

Amy Sellers

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