Z-2564-2014Class II

Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to...

Name: Z-2564-2014 Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to...
Creator: Hitachi Medical Systems America Inc
Published: 2014-08-18
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2014-08-18 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of 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... on 2014-08-18. FDA classified it as Class II and gives the reason as "The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2564-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-18
Posted: 2014-09-02
Terminated: 2015-09-14
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Root cause tag: design
FDA root cause: Device Design
Action: Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
Quantity in commerce: 39 systems
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 codes and lots: Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2564-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2564-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-02

Product code LNH

K113145Class IIEchelon Oval MRI SystemHitachi Medical Systems America, Inc. / cleared 2012-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)