Company: Hitachi Medical Systems America Inc
Date of Enforcement Report: 6/26/2013
ClassL ll:
PRODUCT
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. Recall Number Z-1559-2013
REASON
Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost. If the two datasets have similar anatomy, position, and orientation, the error could potentially lead to a misdiagnosis.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc., Twinsburg, OH on 1/31/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
45 system units
DISTRIBUTION
Nationwide and Mexico
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