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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 Llc: Spectral CT 7500 Systems Recalled for Multiple Software Issues

Agency Publication Date: January 12, 2024
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Summary

Philips North America Llc is recalling 197 Spectral CT 7500 Computed Tomography X-Ray Systems due to multiple software issues that can interfere with the device's functionality. The software defect affects version 5.0.0.X and could lead to system errors or incorrect imaging performance during medical procedures. These specialized X-ray systems were distributed nationwide and internationally between November 2023 and the present. Consumers should contact Philips or their healthcare provider to ensure their specific system receives the necessary software updates or corrective actions.

Risk

The software flaws can cause the CT system to malfunction or produce errors that affect the device's performance during patient scans. This poses a risk of medical complications if diagnostic imaging is delayed, interrupted, or performed incorrectly due to these technical failures.

What You Should Do

  1. Identify if your medical facility uses the Spectral CT 7500 Computed Tomography X-Ray System with Software Version 5.0.0.X.
  2. Check the device serial number and Unique Device Identifier (UDI) against the list of affected units, which includes serial numbers ranging from 10013 to 10193 and 396001 to 397028.
  3. Confirm if your system matches Model Numbers 728333 or 728340.
  4. If you are a patient, contact your healthcare provider to discuss how this software recall may affect your scheduled imaging or previous results.
  5. Medical facilities should contact Philips North America Llc directly to receive instructions regarding software patches, updates, or technical service visits to resolve these issues.
  6. For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall for software issues.

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

Affected Products

Product: Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System
Model / REF:
728333
728340
UPC Codes:
00884838101111
00884838111103
Lot Numbers (197):
Serial No. 10148
Serial No. 10158
Serial No. 10160
Serial No. 10162
Serial No. 10163
Serial No. 10165
Serial No. 10166
Serial No. 10167
Serial No. 397002
Serial No. 397003
Serial No. 397004
Serial No. 397005
Serial No. 397006
Serial No. 397007
Serial No. 397008
Serial No. 397009
Serial No. 397010
Serial No. 397011
Serial No. 397013
Serial No. 397014
Serial No. 397015
Serial No. 10021
Serial No. 10034
Serial No. 10035
Serial No. 10036
Serial No. 10038
Serial No. 10039
Serial No. 10042
Serial No. 10048
Serial No. 10049
Serial No. 10052
Serial No. 10055
Serial No. 10057
Serial No. 10067
Serial No. 10068
Serial No. 10069
Serial No. 10081
Serial No. 10082
Serial No. 10085
Serial No. 10087
Serial No. 10088
Serial No. 10089
Serial No. 10091
Serial No. 10092
Serial No. 10093
Serial No. 10096
Serial No. 10098
Serial No. 10100
Serial No. 10102
Serial No. 10103

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93640
Status: Active
Manufacturer: Philips North America Llc
Sold By: Philips Healthcare; Authorized Medical Device Distributors
Manufactured In: United States
Units Affected: 197 units
Distributed To: Nationwide

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.