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.
FDA Recall Z-1559-2013 · Posted 2013-06-19
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2013-01-31
Date Terminated2013-09-20
Product Quantity45 system units
Reason for Recall
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.
Firm Action
Hitachi sent a Device Correction Notice beginning on January 31,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Software correction is targeted to start by March 1, 2013. All sites will be visited by Hitachi Service to perform corrections. All letters are recorded by tracking number and date received by the customers.
For further questions please call 800-800-3106 x 3720.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.