Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America Llc: Philips Inclusive CT Systems Recalled for Software Display and Imaging Issues

Agency Publication Date: December 18, 2023
Share:
Sign in to monitor this recall

Summary

Philips North America LLC is recalling 330 units of its Philips Inclusive CT whole-body x-ray systems due to three critical software issues. These defects can cause incorrect image displays, errors in reporting patient images, and potential exposure to incorrect functions during clinical procedures. If you have been scanned using one of these affected systems, you should contact your healthcare provider to ensure your results were interpreted correctly. Philips is working to address these software errors to ensure the safety and accuracy of patient diagnostics.

Risk

The software defects can lead to the display of incorrect patient images or data, which may result in a misdiagnosis, delayed treatment, or the administration of unnecessary medical procedures. In some cases, patients may also be exposed to incorrect imaging functions or radiation settings during their scan.

What You Should Do

  1. Identify if your facility is using an affected Philips Inclusive CT system by checking the System Codes 728143 or 728144.
  2. Check your device serial number and Unique Device Identifier (UDI) against the extensive list of affected units, which includes UDIs such as (01)00884838105508(21)34035 and serial numbers ranging from 33002 to 552014.
  3. If you are a patient who recently underwent a scan on one of these systems, contact your healthcare provider to discuss whether the imaging results were impacted by these software issues.
  4. Healthcare facilities should contact Philips North America LLC directly at 1-888-463-6332 or visit their website for specific instructions on software updates and corrective measures.
  5. Follow any specific guidance provided by Philips in the notification letter sent to affected customers on March 29, 2022.
  6. For additional questions or to report further 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

๐Ÿ“‹Other Action

Manufacturer initiated corrective action via notification letter.

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

Affected Products

Product: Philips Inclusive CT Whole-Body X-Ray System
Model / REF:
System Code: 728143
System Code: 728144
Equipment Number: 97127344
Equipment Number: 97127351
Equipment Number: 97127346
Equipment Number: 94808779
Equipment Number: 94878276
Equipment Number: 94808780
Equipment Number: 94984190
UPC Codes:
00884838105508
00884838085015
Lot Numbers:
Serial No. 34035
Serial No. 34029
Serial No. 34030
Serial No. 550007
Serial No. 550009
Serial No. 550068
Serial No. 550012
Serial No. 550044
Serial No. 550049
Serial No. 34021
Serial No. 34076
Serial No. 34094
Serial No. 500519

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93509
Status: Resolved
Manufacturer: Philips North America Llc
Sold By: Authorized Philips medical equipment distributors; Direct sales to hospitals and clinics
Manufactured In: United States
Units Affected: 330 units
Distributed To: Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas

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.