Philips North America Llc is recalling 51 Ingenia Evolution 1.5T and 3.0T Magnetic Resonance (MR) systems equipped with software version R5.7.1. These medical diagnostic systems may fail to provide a warning when ventilation settings are too low, which can cause the patient's body temperature to rise or create a burning sensation during an exam. The recall affects 32 units of the 1.5T model and 19 units of the 3.0T model distributed across several states and international locations.
The software defect prevents the system from alerting operators to inadequate ventilation, which can lead to excessive heating of the patient's body or localized burns during the imaging process.
Manufacturer correction/instruction
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 · 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.