Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hitachi Echelon Oval MRI system is a diagnostic imaging device Recalled by Hitachi Medical Systems America Inc Due to The Gradient Coil was found to have a...
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
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Quantity: 39 systems
Why Was This Recalled?
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
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.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report