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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 Healthcare (Suzhou) Co., Ltd.: Incisive CT Scanners Recalled for Software and Image Defects

Agency Publication Date: January 5, 2024
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Summary

Philips Healthcare (Suzhou) is recalling 828 Incisive CT scanners, specifically models 728143 and 728144 running Software Version 5.0.0. The recall is due to multiple software defects that can cause scanning images to be labeled incorrectly, display visual artifacts, or fail to reconstruct entirely. These issues can lead to a doctor providing an incorrect diagnosis or a patient needing to undergo a repeat CT scan, which involves additional radiation exposure. Additionally, mechanical defects may cause the patient couch to move to the wrong position, and audio failures might prevent patients from hearing instructions during their procedure. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding necessary software updates.

Risk

Software defects in these scanners can cause 2D image labels to be reversed or produce artifacts that obscure medical details, potentially leading to misdiagnosis. Mechanical issues with the patient couch firmware could result in incorrect positioning, while audio failures can cause patients to miss critical instructions during cardiac scans.

What You Should Do

  1. Identify if your medical facility uses the Philips Incisive CT scanner, specifically model 728143 or model 728144 running Software Version 5.0.0.
  2. Check the Unique Device Identifier (UDI-DI) on the equipment: 00884838085015 for Model 728143 or 00884838105508 for Model 728144.
  3. If you are a patient who has recently undergone a scan on one of these systems and have concerns about the accuracy of your results or experienced issues during the scan, contact your healthcare provider immediately.
  4. Healthcare facilities and providers should contact Philips Healthcare (Suzhou) Co., Ltd. directly to receive guidance on software patches and service corrections.
  5. For further information or to report additional 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 service and software correction

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

Affected Products

Product: Incisive CT (Model 728143)
Model / REF:
728143
Lot Numbers:
UDI-DI: 00884838085015
Date Ranges: Software Version 5.0.0
Product: Incisive CT (Model 728144)
Model / REF:
728144
Lot Numbers:
UDI-DI: 00884838105508
Date Ranges: Software Version 5.0.0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93574
Status: Active
Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Sold By: Philips Healthcare Authorized Dealers; Direct Sales to Medical Facilities
Manufactured In: China
Units Affected: 828
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Wisconsin, Puerto Rico

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.