Use cautionMedical device recall · FDA · Published October 9, 2023
Philips Spectral CT on Rails Software Version 5.1.0 Recall: Gantry Misalignment Risk
Philips recalls Spectral CT on Rails with software version 5.1.0 (model 728334) due to risk of gantry misalignment during scans, potentially causing incorrect scans or collisions. Affected units sold from 2020-2021.
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).
Take action
Contact the company
📍Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296
✎ GovInfoNow plain-language explainer
Philips is recalling Spectral CT on Rails machines with software version 5.1.0 because a button press during scans might cause the gantry to move unexpectedly. This could lead to scans being done in the wrong location or physical collisions with the user or medical equipment. Read more at govinfonow.com/recall/57117-philips-spectral-ct-on-rails-software-version-5-1-0.
“Philips Spectral CT on Rails Software Version 5.1.0 Recall: Gantry Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57117-philips-spectral-ct-on-rails-software-version-5-1-0. Based on FDA recall #Z-0319-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2024%22&limit=1).
Philips North America, on behalf of the Food and Drug Administration, recalled one Spectral CT on Rails unit (Model 728334) nationwide in Minnesota on Oct. 9, 2023. The device poses a risk of incorrect scan locations or gantry collisions due to software errors.
How to tell if you have it
Philips Spectral CT on Rails
Software Version 5.1.0
Model Number 728334
UDI-DI: 00884838103627
Lot Code: 1005
The hazard
When using the IVC needle position button 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 an unexpected location, presenting a risk that the scan could occur at an incorrect location or cause a collision with the user or needle.
Context
GovInfoNow's records show Philips North America has 30 other recalls on record since Dec. 24, 2020. Other recent recalls of similar products include Philips Ingenia Elition S and Ingenia Elition X (Aug. 28, 2026), Philips Patient Information Center iX Software Freezes (July 31, 2026), and Philips Ingenia Elition S MRE Scanner Recall: Stiffness Value Errors (April 14, 2026). Additional recent recalls of similar products include Philips Spectral CT on Rails Software Issues: Potential Gantry Stuck During Scans (March 7, 2026), Philips Spectral CT 7500 on Rails Recall: Unsecured Rotor Risk (Jan. 7, 2026), and Philips IQon Spectral CT Software 4.7.7.x Recall: Unintended Radiation Risk (Aug. 7, 2026).
How to tell if you have this one
Check for the model number 728334 and software version 5.1.0 on the device. Units were sold between 2020 and 2021 with UDI-DI: 00884838103627 and lot code 1005.
Brand
Philips
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Spectral CT on Rails device; affected units have version 5.1.0.
Contact Philips Support
Reach out to Philips North America for guidance on potential fixes or updates.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0319-2024 (October 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0319-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.