Philips North America is recalling 423 MRI scanning systems equipped with Magnetic Resonance Elastography (MRE) technology due to a software error that causes incorrect stiffness values. This error occurs when specific image settings are used with the Resoundant algorithm, leading to voxel sizes that display smaller than they actually are. Affected models include various Achieva, Ingenia, and MR 7700 systems, as well as several Evolution and dStream upgrade kits. Philips has initiated this voluntary recall via notification letters to affected hospitals and clinics worldwide.
The software error can result in inaccurate measurement of tissue stiffness, which may lead to incorrect diagnostic conclusions or inappropriate patient management based on faulty scan data. No injuries have been reported to date.
Software correction or field service action
Model 781196 has no UDI listed.
510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
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.