Company:Canon USA, Inc.
Date of Enforcement Report: 6/25/03
Class: II
PRODUCT
Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03.
CODE
RIUpdate 7.1.OK.
RECALLING FIRM/MANUFACTURER
Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing.
REASON
Imaging archive system software mismatches images and patient names.
VOLUME OF PRODUCT IN COMMERCE
34.
DISTRIBUTION
IA, CA, AR, WA, and OR.
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