Philips North America: Spectral CT on Rails Recalled Due to Potential Software Crashes

Agency Publication Date: November 15, 2023

Summary

Philips North America is recalling one unit of the Spectral CT on Rails (Software Version 5.1.0, Model 728334) because the system can experience a software crash during specific operating conditions. This occurs if an operator prepares for CCT Fluoroscopy mode while simultaneously activating the CCT foot pedal, causing the entire system to crash and requiring a full restart. This single affected unit was distributed in Minnesota.

Risk

A software crash during a medical procedure causes the imaging system to stop functioning, requiring a restart that could delay critical diagnostic or surgical interventions.

What You Should Do

Identify if your facility is using the Spectral CT on Rails system with Software Version 5.1.0, Model Number 728334, specifically matching UDI-DI 00884838103627 and Lot Code 1005.
If you are using the affected equipment, avoid simultaneously activating the CCT foot pedal while preparing for CCT Fluoroscopy mode to prevent a software crash.
Contact Philips North America directly at their Cambridge, Massachusetts office or through your local service representative for instructions on software updates or corrective actions.
Contact your healthcare provider or Philips North America for further instructions and information regarding a potential remedy.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and software management

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: 93363

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 · 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.

Summary

What You Should Do

Identify if your facility is using the Spectral CT on Rails system with Software Version 5.1.0, Model Number 728334, specifically matching UDI-DI 00884838103627 and Lot Code 1005.

If you are using the affected equipment, avoid simultaneously activating the CCT foot pedal while preparing for CCT Fluoroscopy mode to prevent a software crash.

Contact Philips North America directly at their Cambridge, Massachusetts office or through your local service representative for instructions on software updates or corrective actions.

Contact your healthcare provider or Philips North America for further instructions and information regarding a potential remedy.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.