Company: Hitachi Medical Systems America Inc.
Date of Enforcement Report: 6/22/05
Class: II
PRODUCT
a) Hitachi Altaire Magnetic Resonance Imaging Device.
Recall # Z-0888-05;
b) Hitachi AIRIS II Magnetic Resonance Imaging Device.
Recall # Z-0889-05;
REASON
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
c) Hitachi AIRIS Elite Magnetic Resonance Imaging Device.
Recall # Z-0890-05.
CODE
a) L001 thru L182;
b) C002 thru C795, C907, and C910;
c) H003 thru H059
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on April 21, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
983 devices
DISTRIBUTION
Nationwide, Wales and London
