Company: Hitachi Medical Systems America, Inc.,
Date of Enforcement Report:6/21/2006
Class:lI
PRODUCT
Altaire Nuclear Magnetic Resonance Imaging Device Systems, Recall # Z-1104-06
REASON
Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
CODE
Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on March 17, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
283 devices
DISTRIBUTION
Nationwide
