Z-1559-2013Class II

Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and...

Name: Z-1559-2013 Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and...
Creator: Hitachi Medical Systems America Inc
Published: 2013-01-31
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2013-01-31 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of 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... on 2013-01-31. FDA classified it as Class II and gives the reason as "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...". 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-1559-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-31
Posted: 2013-06-19
Terminated: 2013-09-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Hitachi sent a Device Correction Notice beginning on January 31,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is targeted to start by March 1, 2013. All sites will be visited by Hitachi Service to perform corrections. All letters are recorded by tracking number and date received by the customers. For further questions please call 800-800-3106 x 3720.
Quantity in commerce: 45 system units
Distribution: Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.
Product codes and lots: The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1559-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-19

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)