Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 22, 2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America recalled Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 - a moderate-severity action.
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 was recalled by Philips North America in November 22, 2023. Reason: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on th…. Check the official notice for the remedy. Verify recall #Z-0319-2024 with the FDA Devices before acting.
The recall
Philips North America issued this moderate-severity FDA Devices recall-This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on th….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- November 22, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0319-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0319-2024) was formally reported on November 22, 2023, with the manufacturer initiating the action on October 9, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips North America is listed as the recalling firm, operating out of Cambridge, MA. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This iss… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of MN.. 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 unit
Related Recalls
6
3 from same agency
Product description
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason for recall
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0319-2024 |
| Date reported | November 22, 2023 |
| Date initiated | October 9, 2023 |
| Recalling firm | Philips North America |
| Firm location | Cambridge, MA |
| Affected scope | 1 unit |
| Distribution | US Nationwide distribution in the state of MN. |
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-0319-2024) 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? ▼
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334. Recalled by Philips North America. Units affected: 1 unit.
Why was this product recalled? ▼
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0319-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of MN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0319-2024) 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 November 22, 2023. 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.