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Device recall: Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the phy
FDA enforcement event 68758 is a device recall by Hitachi Medical Systems America Inc of Twinsburg, OH, initiated 18 Aug 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 14 Sep 2015. Initiation: voluntary: firm initiated. Hitachi Medical Systems America Inc has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hitachi Medical Systems America Inc, Twinsburg, OH.
Reason for recall
"The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard."
Distribution
"Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2564-2014 | 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. | 39 systems | Class II | Terminated | 10 Sep 2014 |
Context
Other enforcement events for Hitachi Medical Systems America Inc
All 15 events for Hitachi Medical Systems America Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.