Philips IQon Spectral CT Software Version 4.7.0/4.7.2 May Cause Misleading Patient Reports
Philips recalls IQon Spectral CT scanners with software versions 4.7.0 or 4.7.2 due to potentially misleading calcium score reports that could lead to incorrect patient treatment decisions.
Lower-risk recall
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Contact the company
What happened, in plain English
Philips is recalling certain IQon Spectral CT scanners with specific software versions because they may generate confusing calcium score reports. This could lead to incorrect patient treatment decisions if healthcare providers rely on the misleading information. Read more at govinfonow.com/recall/73899-philips-iqon-spectral-ct-software-version-4-7-0-4.
Source Summary by GovInfoNow · govinfonow.com/recall/73899-philips-iqon-spectral-ct-software-version-4-7-0-4 · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0306-2019
Cite this page
“Philips IQon Spectral CT Software Version 4.7.0/4.7.2 May Cause Misleading Patient Reports.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73899-philips-iqon-spectral-ct-software-version-4-7-0-4. Based on FDA recall #Z-0306-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2019%22&limit=1).
Why it’s dangerous
Scanners running certain software versions produce multiple calcium score analyses in the 'Impressions' section that appear to apply simultaneously. This misleading guidance could lead healthcare providers to make incorrect treatment decisions based on the reports.
Who’s affected
Healthcare providers using Philips IQon Spectral CT scanners with software versions 4.7.0 or 4.7.2 are most at risk. Patients receiving scans from these systems may be affected if the reports are misinterpreted.
How to tell if you have this one
Check if your IQon Spectral CT scanner has software version 4.7.0 or 4.7.2. The product is used for computed tomography X-ray imaging and may include signal analysts and display equipment.
- Brand
Philips Medical Systems- Category
Medical device
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0303-2019 | Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; Software version 4.2.0 | 145 |
| Z-0304-2019 | Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; Software Version 4.1.6 | 1890 |
| Z-0305-2019 | Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; Software Version 4.1.6 | 626 |
| Z-0306-2019 | IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; software versions 4.7.0 or 4.7.2 | 64 |
| Z-0307-2019 | Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; software version 4.2.0 | 145 |
| Z-0308-2019 | Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; software versions 4.1.6 | 1890 |
| Z-0309-2019 | Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; software versions 4.1.6 | 1890 |
| Z-0310-2019 | Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; software version 4.1.6 | 1890 |
| Z-0311-2019 | Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.; Software Version 4.7.0 or 4.7.2 | 626 |
What to do — step by step
Check Software Version
Verify your scanner's software version by checking the device settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-0306-2019 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0306-2019 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.