Jun

2010

Cl Il Horizon Medical Imaging Systems

Company:Mckesson Medical Imaging
Date of Enforcement Report 6/15//2010
Class:ll

PRODUCT
Voiceware clip software update to certain Horizon Medical Imaging Systems. 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 # Z-1735-2010

REASON
Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.

RECALLING FIRM/MANUFACTURER
Mckesson Medical Imaging, Richmond British Columbia, Canada, by letter dated May 7, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
100 units

DISTRIBUTION
Nationwide and Canada

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 Il Horizon Medical Imaging Systems

Amy Sellers

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