Z-2839-2018Class II

Hitachi Scenaria CT system

Name: Z-2839-2018 Hitachi Scenaria CT system
Creator: Hitachi Medical Systems America Inc
Published: 2018-06-29
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2018-06-29 / Terminated / root cause: manufacturing process

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications... on 2018-06-29. FDA classified it as Class II and gives the reason as "The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The...". 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-2839-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-08-17
Terminated: 2020-04-27
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. 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), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 6/19/18, the firm was notified of the problem at a customer site. The firm is currently investigating the underlying cause to formulate a planned corrective action. On 6/29/18, the firm took a preventive measure at the site which originated the complaint: Hitachi added an optional touch sensor to the unit to lessen the chance of injury. The firm may take additional corrective action on other units distributed to customers once root cause investigation is complete.
Quantity in commerce: 1
Distribution: US Distribution to one customer in TX.
Product codes and lots: S7004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2839-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2839-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code JAK

K150595Class IISCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. / cleared 2015-10-30

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)