Z-2479-2018Class II

Hitachi Oasis MRI system

Name: Z-2479-2018 Hitachi Oasis MRI system
Creator: Hitachi Medical Systems America Inc
Published: 2018-06-18
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2018-06-18 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical... on 2018-06-18. FDA classified it as Class II and gives the reason as "The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have...". 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-2479-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-18
Posted: 2018-07-18
Terminated: 2020-04-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.
Root cause tag: design
FDA root cause: Device Design
Action: On June 18, 2018, the firm distributed an Urgent Medical Device Correction Notices to affected customers. Customers were informed of the issue and advised that the firm would be adding protective guards to both sides of the belt to prevent accidental contact. The firm expects to begin installing the guards around fall 2018. In the meantime, customers are advised to avoid direct contact with the stainless steel belt. Questions, comments, or requests may be sent to [email protected].
Quantity in commerce: 264
Distribution: Worldwide Distribution - US Nationwide distribution.in the states of Mexico.
Product codes and lots: M001 to M028, M030 to M108, M110 to M266, M951, M952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2479-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2479-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18

Product code LNH

K093044Class IIOasis MRI SystemHitachi Medical Systems America, Inc. / cleared 2010-03-16

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)