Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system Recalled by Hitachi Medical Systems America Inc Due to The firm received a complaint where, during patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Medical Systems America Inc directly.
Affected Products
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.
Quantity: 1
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: TX
About Hitachi Medical Systems America Inc
Hitachi Medical Systems America Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report