Use caution Medical device recall · FDA · Published November 16, 2024

Philips Spectral CT Recall: Risk of Collision or Misdiagnosis During Procedures

Philips recalls Spectral CT and Spectral CT Plus models 728333, 728340, 728344 due to potential collision with operator or misdiagnosis risks during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0583-2025Medical device Philips ›

Use caution until it’s fixed

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling Spectral CT and Spectral CT Plus models 728333, 728340, and 728344 because they may cause collisions with medical staff or lead to incorrect patient diagnoses during procedures. Read more at govinfonow.com/recall/53481-philips-spectral-ct-recall-risk-of-collision-or-misdiagnosis-during.

Source Summary by GovInfoNow · govinfonow.com/recall/53481-philips-spectral-ct-recall-risk-of-collision-or-misdiagnosis-during · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0583-2025

Cite this page

“Philips Spectral CT Recall: Risk of Collision or Misdiagnosis During Procedures.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53481-philips-spectral-ct-recall-risk-of-collision-or-misdiagnosis-during. Based on FDA recall #Z-0583-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0583-2025%22&limit=1).

The FDA announced on November 16, 2024, that Philips North America LLC is recalling Spectral CT and Spectral CT Plus imaging devices due to potential software issues. The hazard includes a plan box not updated during interventional procedures and incorrect patient ID data that may lead to misdiagnosis.

How to tell if you have it

Brand: Philips
Product names: Spectral CT, Spectral CT Plus
Model numbers: 728333, 728340, 728344
UPC: 00884838101111
Units affected: 301

The hazard

The recall cites a potential for a plan box not being updated during interventional procedures with Spectral CT, which may lead to a collision with the operator or the needle placed inside the patient. Additionally, an incorrect patient ID software issue may lead to misdiagnosis.

Context

GovInfoNow's records show Philips North America LLC has issued 129 other recalls since July 12, 2017. Recent similar recalls include Philips Spectral CT 7500 Scanner May Cause Extra Radiation Exposure (August 18, 2026) and Philips IQon Spectral CT Upgrades: Risk of Inadequate Scans and Extra Radiation (June 11, 2026).

How to tell if you have this one

Check for model numbers 728333, 728340, or 728344 on the device. These models were sold with software version 5.0.X and serial numbers listed in the recall notice.

Brand
Philips
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on your Spectral CT or Spectral CT Plus device to confirm if it's affected.
Contact Philips Support
Reach out to Philips customer support for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 19 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Florida, Georgia, Hawaii, Indiana, Kentucky, Maryland, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, West Virginia.

Recall timeline

FDA published this recall 25 days after the firm started it.

Nov 16, 2024Firm started the recall
Dec 3, 2024FDA classified it Class II
Dec 11, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53481-philips-spectral-ct-recall-risk-of-collision-or-misdiagnosis-during">Philips Spectral CT Recall: Risk of Collision or Misdiagnosis During Procedures (GovInfoNow)</a>

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-0583-2025 (November 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0583-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.