Z-1534-2010

Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The

Name: Z-1534-2010 Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The
Creator: Hitachi Medical Systems America Inc
Published: 2009-09-01
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2009-09-01 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved... on 2009-09-01. The reason FDA records is "The device has a software error that could potentially lead to a misdiagnosis". 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-1534-2010
Status: Terminated
Initiated: 2009-09-01
Posted: 2010-05-04
Terminated: 2012-02-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
Product code: IWE Monitor, Patient Position, Light-Beam
Reason for recall: The device has a software error that could potentially lead to a misdiagnosis.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Sites have already been corrected. Software updated from V1.0C to V2.0B
Quantity in commerce: 43
Distribution: Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY.
Product codes and lots: Model #'s: M001 - M043

Product code IWE

K072279Class IIMagnetic Resonance Diagnostic DeviceHitachi Medical Systems America, Inc. / cleared 2007-09-21

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)