Aug

2005

Inc Class III Konica Medical Imaging

Company: Konica Medical Imaging, Inc,
Date of Enforcement Report: 8/24/05
Class: III

PRODUCT
Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05

REASON
One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Konica Medical Imaging, Inc, Wayne, NJ, by telephone, visit, and letter, beginning on April 7, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
60 units

DISTRIBUTION
Nationwide

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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Inc Class III Konica Medical Imaging

Amy Sellers

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