Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2012
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.
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 reconst…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hitachi Medical Systems America Inc recalled Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated t… - a moderate-severity action.
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated t… was recalled by Hitachi Medical Systems America Inc in July 25, 2012. Reason: Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that …. Check the official notice for the remedy. Verify recall #Z-2037-2012 with the FDA Devices before acting.
The recall
Hitachi Medical Systems America Inc issued this moderate-severity FDA Devices recall-Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that ….
- Moderate
- severity level
- Class II
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2037-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2037-2012) was formally reported on July 25, 2012, with the manufacturer initiating the action on May 4, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Hitachi Medical Systems America Inc is listed as the recalling firm, operating out of Twinsburg, OH. Federal records list the affected scope as Six (6) units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Six (6) units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2037-2012 |
| Date reported | July 25, 2012 |
| Date initiated | May 4, 2012 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Firm location | Twinsburg, OH |
| Affected scope | Six (6) units |
| Distribution | US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2037-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hitachi Medical Systems America Inc. Units affected: Six (6) units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2037-2012.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2037-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.