Hitachi Scenaria CT System Software Product Usage: The Scenaria… — Class II medical device recall Z-2037-2012
Terminated recall by Hitachi Medical Systems America Inc, reported 2012-07-25, distributed nationwide. Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a
| Recall number | Z-2037-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2012-05-04 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Reason classes | software |
| Serial numbers | S5001, S5011 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2037-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.