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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: Incisive CT Systems Recalled Due to Risk of Flying Components

Agency Publication Date: May 20, 2024
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Summary

Philips North America Llc is recalling 173 Incisive CT (Computed Tomography) X-Ray Systems because a metal mounting box inside the scanner's rotating part may break or loosen. If this occurs while the machine is spinning, it can strike other internal parts and cause a fragment to be thrown out at low speed. This defect affects model numbers 728143 and 728144 which were distributed nationwide in the United States and worldwide. Philips initiated this recall via letter to ensure these medical devices are properly inspected and corrected to prevent potential damage or injury during diagnostic imaging.

Risk

A metal component inside the gantry (the rotating part of the CT scanner) can become compromised and make contact with other moving parts during high-speed rotation. This contact can cause pieces of the internal machinery to break off and be expelled from the system, posing a physical injury risk to patients or medical staff in the vicinity.

What You Should Do

  1. Identify if your facility is using an affected Incisive CT system by checking the model and serial numbers. Affected systems include Model 728143 with serial numbers: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211, 500216, 500217, 500222, 500225, 500230, 500240, 500242, and 500615.
  2. Check for affected Model 728144 units using serial numbers such as 34002, 34006, 34018, 34019, 34023, 34025, 34026, 34031, 34032, 34033, 34038, 34040, 34041, 34042, 34047, 34049, 34050, 34051, 34052, 34053, 34054, 34055, 34056, 34057, 34058, 34059, 34060, 34064, 34066, 34067, 34068, 34071, 34072, 34073, 34074, 34075, 34077, 34078, 34079, 34080, 34081, 34082, 34083, 34085, 34086, 34088, 34089, 34090, 34091, 34092, 34093, 34095, 34097, 34100, 34101, 34102, 34103, 34105, 34106, 34111, 34112, 34116, 34117, 34119, 34122, 34126, 34128, 34130, 34131, 34132, 34133, 34134, 34135, 34137, 34146, 34149, 34150, 34152, 34153, 34160, 34162, 34163, 34164, 34165, 34168, 34169, 34174, 34175, 34179, 34187, 34190, 34191, 34193, 34195, 34198, 34201, 34203, 34206, 34208, 34218, 34221, 34223, 34226, 34229, 34235, 34240, 34244, 34251, 34257, 34259, 34260, 34263, 34264, 34265, 34267, 34270, 34276, 34277, 34279, 34280, 34281, 34282, 34285, 34289, 34294, 34295, 34301, 34315, 34324, 34325, 34326, 34327, 34335, 34337, 34338, 34344, 34348, 34350, 34351, 34358, 34367, 34368, 34374, 34384, 34385, 550243, and 550503.
  3. If you own or operate one of these systems, immediately contact Philips North America Llc at their Cambridge, MA headquarters or your local service representative to schedule a correction or inspection.
  4. Follow any specific guidance provided in the notification letter sent by Philips regarding the continued use of the equipment until a technician has addressed the issue.
  5. Contact your healthcare provider or Philips North America Llc for further instructions and potential refund or repair details.
  6. For additional questions, contact the FDA Medical Device Recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/inspection

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 / REF:
728143
UPC Codes:
00884838085015
Lot Numbers:
500046
500064
500074
500102
500110
500111
500145
500168
500178
500211
500216
500217
500222
500225
500230
500240
500242
500615
Product: Incisive CT - Computed Tomography X-Ray System
Model / REF:
728144
UPC Codes:
00884838105508
Lot Numbers (149):
34002
34006
34007
34018
34019
34023
34025
34026
34031
34032
34033
34038
34040
34041
34042
34047
34049
34050
34051
34052
34053
34054
34055
34056
34057
34058
34059
34060
34064
34066
34067
34068
34071
34072
34073
34074
34075
34077
34078
34079
34080
34081
34082
34083
34085
34086
34088
34089
34090
34091

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94536
Status: Active
Manufacturer: Philips North America Llc
Sold By: Direct sales; Medical equipment distributors
Manufactured In: United States
Units Affected: 2 products (18 units; 155 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.

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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.