Hitachi Medical Systems America Inc: 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.

Recall number

Z-2839-2018

Recalling firm

Hitachi Medical Systems America Inc

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.

Status

Terminated

Initiated

2018-06-29

Posted

not on file

Terminated

2020-04-27

Reason

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

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

1

Distribution

US Distribution to one customer in TX.

Lot, serial or model codes

S7004

510(k) numbers

["K150595"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1528028

Firm city

Twinsburg

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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