Z-2037-2012Class II

Hitachi Scenaria CT System Software

Name: Z-2037-2012 Hitachi Scenaria CT System Software
Creator: Hitachi Medical Systems America Inc
Published: 2012-05-04
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2012-05-04 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images... on 2012-05-04. FDA classified it as Class II and gives the reason as "Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a...". 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-2037-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Posted: 2012-07-19
Terminated: 2013-02-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
Root cause tag: software
FDA root cause: Software design
Action: Hitachi sent a "Device Correction Notice" dated May 4, 2012 to their customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to "not use the Reconstruction Status" function to suspend active reconstructions until the software problem can be corrected. They also informed their customers that a representative will visit their facility to install the software update to permanently resolve the issue at no cost to the facility. For further information regarding this notice call 800-800-3106 x3720.
Quantity in commerce: Six (6) units
Distribution: US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
Product codes and lots: Serial #'s S5001 - S5011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2037-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2037-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)