Z-2392-2016Class II

Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087

Name: Z-2392-2016 Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Creator: Hitachi Medical Systems America Inc
Published: 2015-06-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-06-30 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 on 2015-06-30. FDA classified it as Class II and gives the reason as "The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient". 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-2392-2016
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2016-08-11
Terminated: 2016-11-01
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
Root cause tag: design
FDA root cause: Component design/selection
Action: Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.
Quantity in commerce: 33 units
Distribution: US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Product codes and lots: Serial #'s: S5002-S5014; S5017-S5038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2392-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2392-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code JAK

K101888Class IIScenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. / cleared 2011-04-08

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)