23

May

2006

Inc., Class II Konica Minolta Medical Imaging USA

0

Company: Konica Minolta Medical Imaging USA, Inc.,
Date of Enforcement Report:5/23/2006
Class:lI

PRODUCT
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. The Konica REGIUS Image Manager Software (RIM) is used to receive and manage computerized X-Ray image file workflow, Recall # Z-0862-06

REASON
If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.

CODE
Units distributed between June 2003 and January 2006. Software version prior to January 31, 2006

RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on February 6, 2006, followed with a fax, e-mail and letter.
Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan, firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
58 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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