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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 Systems Recalled for Patient Interface Monitor Cable Failure

Agency Publication Date: January 12, 2024
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Summary

Philips North America is recalling 55 Incisive CT systems in the United States (and 1,029 internationally) because the Patient Interface Monitor (PIM) cable may fail. Frequent plugging and unplugging of the cable can cause the internal wires to disconnect from their welding points, leading to an intermittent loss of the ECG signal. If the signal is lost during a medical procedure, doctors may be forced to rescan the patient or experience critical delays in diagnosis during clinical emergencies. This recall affects Model Numbers 728144 and 728143 configured with the specific PIM cable part number 459801179871.

Risk

The mechanical stress of daily operation causes the cable connector to detach from its internal welding point, resulting in a loss of the electrocardiogram (ECG) data stream. This failure disrupts heart monitoring during imaging, which can lead to unnecessary radiation exposure from rescanning or delayed medical intervention during life-threatening emergencies.

What You Should Do

  1. Locate the connection cable between your ECG monitor and the Incisive CT gantry to identify if your system is affected.
  2. Check the part number on the PIM cable to see if it matches 459801179871.
  3. Verify your system's serial number against the affected list: For Model 728143, check for serials including 33007, 33038, 33013, 33006, 33012, 33045, 33011, 500102, 33015, 33005, 33041, 33047, 500217, 500255, 33035, 500252, 500145, 500046, 500168, 33009, 33046, 33024, 500222, 500064, 33034, 500242, 500301, 33010, 33019, 33001, 33020, 33031, 33037, 500110, 500111, 500178, 33003, 500282, 33002, or 33033.
  4. Verify your system's serial number for Model 728144, including: 34002, 34051, 34050, 34041, 34059, 34057, 34054, 34040, 34007, 34026, 34058, 34049, 34056, or 34052.
  5. Contact your healthcare provider or Philips North America directly to discuss the equipment defect and arrange for necessary technical support or cable replacement.
  6. For further information or to report issues, 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 notification and technical support.

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

Affected Products

Product: Incisive CT Computed Tomography X-Ray System (Model 728143)
Model / REF:
728143
459801179871 (PIM Cable)
UPC Codes:
00884838085015
Lot Numbers:
33007
33038
33013
33006
33012
33045
33011
500102
33015
33005
33041
33047
500217
500255
33035
500252
500145
500046
500168
33009
33046
33024
500222
500064
33034
500242
500301
33010
33019
33001
33020
33031
33037
500110
500111
500178
33003
500282
33002
33033
Product: Incisive CT Computed Tomography X-Ray System (Model 728144)
Model / REF:
728144
459801179871 (PIM Cable)
UPC Codes:
00884838105508
Lot Numbers:
34002
34051
34050
34041
34059
34057
34054
34040
34007
34026
34058
34049
34056
34052

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93654
Status: Active
Manufacturer: Philips North America
Sold By: Direct to hospitals and healthcare facilities
Manufactured In: United States
Units Affected: 55 US; 1029 ROW
Distributed To: Alabama, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Washington

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.