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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 Defects

Agency Publication Date: April 16, 2026
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Summary

Philips is recalling three Spectral CT on Rails diagnostic imaging systems (Model 728334) due to software defects that can cause the gantry to stay in the wrong position during a scan, fail to display important prompts, or disable specific dose-adjustment options. While no injuries have been reported, these issues can lead to improper imaging or incorrect radiation dose settings for brain scans. These systems were distributed in Minnesota as well as France and the Netherlands.

Risk

A software error may cause the scanner's gantry to remain stationary when it should move, potentially leading to inaccurate imaging or radiation delivery to the wrong location. Additionally, software bugs may prevent operators from properly adjusting radiation doses for head scans, which could result in suboptimal imaging or unexpected radiation exposure levels.

What You Should Do

  1. Identify your system by checking the model number (728334), software version (5.1.X), and serial number (1005, 1006, or 1007) located on the device label.
  2. Stop using the recalled device.
  3. Contact Philips Medical Systems or your authorized distributor to arrange for a software correction or further instructions.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

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

Affected Products

Product: Philips Spectral CT on Rails
Variants: Software Version Number: 5.1.X
Model / REF:
728334
Serial Numbers:
1005
1006
1007
UDI:
(01)00884838103627(21)1005
(01)00884838103627(21)1006
(01)00884838103627(21)1007

Firm initiated recall via letter.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98588
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS
Sold By: Philips Medical Systems; Direct distribution
Manufactured In: United States
Units Affected: 3
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.