Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hitachi Scenaria CT System Software Product Usage: The Scenaria system Recalled by Hitachi Medical Systems America Inc Due to Hitachi discovered a software error in the Reconstruction...
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 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.
Quantity: Six (6) units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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