Z-2254-2012Class II

Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices

Name: Z-2254-2012 Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices
Creator: Hitachi Medical Systems America Inc
Published: 2012-06-15
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2012-06-15 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices... on 2012-06-15. FDA classified it as Class II and gives the reason as "Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2254-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Posted: 2012-08-23
Terminated: 2013-02-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu
Root cause tag: software
FDA root cause: Software design
Action: Hitachi sent a Device Correction Notice letter dated June 18, 2012 to all affected customers. All letters are recorded by tracking number and date received by the consignee. The letter identified the affect product, problem and actions to be taken. All sites will be visited by Hitachi Service to install the software update to permanently resolve the issue at no cost to the facility. Software correction is targeted to start by September 1, 2012. For question contact the Manager of Regulatory Affairs at 800-800-3106 x3720
Quantity in commerce: 165 units
Distribution: US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
Product codes and lots: Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2254-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code LNH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)