Z-1541-2017Class II

Hitachi Echelon Oval MRI System

Name: Z-1541-2017 Hitachi Echelon Oval MRI System
Creator: Hitachi Medical Systems America Inc
Published: 2015-04-16
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-04-16 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Echelon Oval MRI System on 2015-04-16. FDA classified it as Class II and gives the reason as "Image data transferred from the MRI system to a workstation showed errors on the slice position reference image". 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-1541-2017
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Posted: 2017-03-23
Terminated: 2017-06-29
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Echelon Oval MRI System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits.
Quantity in commerce: 25 units
Distribution: US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902. There are zero (0) Canada accounts for this recall. There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170 The product was distributed to the following countries: Brazil.
Product codes and lots: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1541-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1540-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-23
Z-1541-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-23
Z-1542-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-23

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