Z-1096-2017Class II

Hitachi Oasis MRI System - C-Spine Coil

Name: Z-1096-2017 Hitachi Oasis MRI System - C-Spine Coil
Creator: Hitachi Medical Systems America Inc
Published: 2017-01-06
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-01-06 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Oasis MRI System - C-Spine Coil on 2017-01-06. FDA classified it as Class II and gives the reason as "The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam". 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-1096-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-06
Posted: 2017-01-26
Terminated: 2018-11-08
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Oasis MRI System - C-Spine Coil
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Root cause tag: design
FDA root cause: Component design/selection
Action: Hitachi sent an Urgent : Device Correction Notice dated January 3, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to visit each site and replace the cable balun and also confirm receipt of the notification letter. The firm will quarantine returned baluns in their warehouse until they are reworked. For further questions regarding this recall please call (330) 425-1313 ext. 3720.
Quantity in commerce: 180 units
Distribution: USA (nationwide) distribution. The product was 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, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Product codes and lots: M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1096-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1096-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26

Product code LNH

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)