Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Echelon Recalled by Hitachi Medical Systems America Inc Due to Hitachi discovered a software error that can occur...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Medical Systems America Inc directly.
Affected Products
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.
Quantity: 45 system units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hitachi Medical Systems America Inc
Hitachi Medical Systems America Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report