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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 Spectral CT on Rails Recalled for Software and Movement Issues

Agency Publication Date: March 12, 2025
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Summary

Philips Medical Systems Nederland B.V. has recalled one unit of the Spectral CT on Rails (Model number 728334) running Software Version Number 5.1.0. The recall was initiated because software errors can cause scanning and image issues, along with unintended movement of the device. No incidents or injuries have been reported in connection with these software problems.

Risk

The software defect could cause the imaging equipment to move unexpectedly or produce inaccurate medical images. This poses a risk of physical injury to patients or staff and could lead to incorrect medical diagnoses or delayed treatment.

What You Should Do

  1. This recall affects the Philips Spectral CT on Rails, Model number 728334, running Software Version Number 5.1.0 with Serial Number 1005.
  2. Stop using the recalled device immediately to prevent scanning errors or unintended movement.
  3. Contact Philips Medical Systems Nederland B.V. or your authorized distributor to arrange for a software correction, repair, or return of the equipment.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Spectral CT on Rails
Variants: Software Version Number 5.1.0
Model / REF:
728334
Serial Numbers:
1005
UDI:
00884838103627

Quantity: 1 unit distributed in Minnesota.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96423
Status: Active
Manufacturer: Philips Medical Systems Nederland B.V.
Sold By: Direct distribution
Manufactured In: Netherlands
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.