Z-2366-2015Class II

Oasis Coil Extension Cable used with Hitachi Oasis MRI System

Name: Z-2366-2015 Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Creator: Hitachi Medical Systems America Inc
Published: 2014-04-25
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2014-04-25 / Terminated / root cause: manufacturing process

FDA source

Hitachi Medical Systems America Inc began a recall of Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician... on 2014-04-25. FDA classified it as Class II and gives the reason as "The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2366-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Posted: 2015-08-10
Terminated: 2018-08-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis 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 cross-sectional 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. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720.
Quantity in commerce: 173 units
Distribution: US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico.
Product codes and lots: Serial #'s: M001to M108, M110 to M175, M951 & M952.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2366-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2366-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10

Product code MOS

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