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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America: Spectral CT on Rails Recalled for Potential Gantry Collisions

Agency Publication Date: November 16, 2023
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Summary

Philips North America is recalling one Spectral CT on Rails system, software version 5.1.0, due to a control system defect. When using the IVC needle position button during scans, the plan box may fail to move correctly, causing the gantry to move to an unexpected location. This specific unit (Model 728334, Lot 1005) was distributed in Minnesota.

Risk

Unexpected movement of the gantry poses a risk of physical collision with the medical operator or the biopsy needle. Additionally, if the gantry moves incorrectly, medical scans may occur at the wrong anatomical location, potentially impacting diagnosis or treatment.

What You Should Do

  1. Identify if you are using the Spectral CT on Rails system, Software Version 5.1.0, Model Number 728334.
  2. Verify the device identification by checking for UDI-DI 00884838103627 and Lot Code 1005.
  3. Contact Philips North America immediately to discuss the software issues, including the gantry movement failure and potential software crashes associated with the CCT foot pedal.
  4. Contact your healthcare provider or Philips North America for further instructions and potential remedy information regarding this specific system.
  5. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Spectral CT on Rails, Software Version 5.1.0
Model / REF:
728334
UPC Codes:
00884838103627
Lot Numbers:
1005

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93362
Status: Active
Manufacturer: Philips North America
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.