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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: Incisive CT X-Ray Systems Recalled for Tabletop Collision Risk

Agency Publication Date: April 9, 2024
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Summary

Philips North America is recalling 428 units of the Incisive Computed Tomography (CT) X-ray system due to a software error. During the initialization of a scan, the patient tabletop may unexpectedly move to its 'home' position. This movement can occur without warning, potentially causing the tabletop to collide with an operator or bystander standing at the rear of the table. The affected devices include systems running Incisive CT Software versions upgraded from V4.5.1.41921 to V4.5.1.41989.

Risk

The patient tabletop can move unexpectedly toward the rear of the machine during startup, creating a crush or impact hazard. This poses a risk of physical injury to hospital staff or bystanders who may be standing in the path of the moving table.

What You Should Do

  1. Identify if your system is affected by checking the Model Number (728143) and matching the serial number against the 428 affected units, which include numbers such as 500092, 500202, 500264, 530147, and 540000.
  2. Verify if your system is running the specific software upgrade from version V4.5.1.41921 to V4.5.1.41989.
  3. Ensure that operators and bystanders do not stand at the rear of the CT table during scan initialization to avoid potential collision with the tabletop.
  4. Contact Philips North America or your healthcare facility's biomedical engineering department to schedule the necessary software correction or inspection.
  5. Contact your healthcare provider or Philips North America for further instructions regarding the safe operation of this device and any potential remedies.
  6. For additional questions, contact the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Device Correction

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

Affected Products

Product: PHILIPS Incisive Computed tomography X-ray system (Incisive CT Software Upgrade V4.5.1.41921 to V4.5.1.41989)
Model / REF:
728143
UPC Codes:
00884838085015
Lot Numbers (428):
500092
500202
500264
500265
33002
500217
500046
33001
33003
500064
500102
500110
500111
500145
500168
500178
500211
500216
500222
500242
500252
500255
500282
500032
500073
500138
500034
500038
500069
500091
500135
500087
500041
500056
500089
500103
500105
500116
500123
500125
500136
500152
500200
500213
500219
500233
500256
500045
500024
500028

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94229
Status: Active
Manufacturer: Philips North America
Sold By: Authorized Medical Device Distributors; Direct Sales
Manufactured In: United States
Units Affected: 428 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.