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.
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.
Manufacturer service and software correction
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.
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.