23
Mar
2016

Cl II McKesson Horizon Medical Imaging

0

Company: Mckesson Medical Immaging
Date of Enforcement Report 3/23/2016
Class lI:

PRODUCT

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. Recall Number Z-1182-2016

REASON
McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.

RECALLING FIRM/MANUFACTURER
Mckesson Medical Immaging, Richmond, British Columbia on 3/17/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
631 devices

DISTRIBUTION
Nationwide and Internationally

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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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