Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 2018
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 reconstruct
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hitachi Medical Systems America Inc recalled Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for hea… - a moderate-severity action.
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for hea… was recalled by Hitachi Medical Systems America Inc in August 29, 2018. Reason: The firm received a complaint where, during patient positioning, the technologist was adjusting the patient t…. Check the official notice for the remedy. Verify recall #Z-2839-2018 with the FDA Devices before acting.
The recall
Hitachi Medical Systems America Inc issued this moderate-severity FDA Devices recall-The firm received a complaint where, during patient positioning, the technologist was adjusting the patient t….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- August 29, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2839-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2839-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on June 29, 2018. 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 1.
The documented reason for this recall is: 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 proble… Distribution data in the federal record shows the product reached: US Distribution to one customer in 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
1
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2839-2018 |
| Date reported | August 29, 2018 |
| Date initiated | June 29, 2018 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Firm location | Twinsburg, OH |
| Affected scope | 1 |
| Distribution | US Distribution to one customer in 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-2839-2018) 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 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.. Recalled by Hitachi Medical Systems America Inc. Units affected: 1.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2839-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to one customer in TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2839-2018) 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 August 29, 2018. 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.