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
