Vitrea Enterprise Cl Il Vitrea 5.1. Vitrea fX 3.0

Company:Vital Images, Inc.
Date of Enforcement Report 5/26//2010
Class:ll

PRODUCT
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010

REASON
Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2., because incorrect measurements may result.

RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated 23 February 2010. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
95 units

DISTRIBUTION
Nationwide and Internationally

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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