MedicalCommunications GmbH is recalling approximately 474 units of its Ashvins variant HEYEX 2 and HEYEX PACS software. The recall affects software versions 2.6.0 (Build 2088) through 2.6.8 (Build 2220). This recall was initiated because the software may calculate area measurements that are smaller than the actual area, which could affect medical diagnoses. If your facility uses this software, contact your software administrator or the manufacturer for instructions on updates or corrections.
The software may provide measurement values smaller than the actual area being measured. This inaccuracy could lead healthcare providers to make incorrect clinical decisions or diagnoses based on undervalued measurements of anatomical structures or lesions.
Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
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.