Philips Ultrasound, Inc. is recalling 363 units of its 5000 Compact Series Ultrasound Systems, specifically models 5500 and 5300 manufactured before December 20, 2023. These systems, when used with certain cart options and multiport adapters, have a software defect where a transesophageal echocardiography (TEE) transducer can remain powered even when not selected for imaging. This can cause the transducer tip to overheat without the system’s temperature monitoring or control systems being active, potentially leading to patient internal burns during medical procedures.
The ultrasound system may fail to properly manage power to an unselected TEE transducer, causing the device to exceed safe temperature limits. Because the temperature monitoring and safety controls are inactive in this specific state, the transducer can reach temperatures that cause serious internal tissue burns to the patient.
Manufacturer correction/instruction
Image 1 – Deluxe Macarons Party Edition, front of package
Image 2 – Deluxe Macarons Party Edition, back of package
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 · FDA Press Release · 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.