PIE Medical Imaging B.V. is recalling 501 units of its 3mensio Workstation (Vascular Fenestrated) software, specifically versions 10.6 and 10.7. The software contains a defect where measurements do not correctly update when a user changes the reference clock position during heart and blood vessel analysis. This error can cause surgeons to place stent grafts in the incorrect location, potentially causing blood flow disruption or tissue damage. While no injuries have been reported, the manufacturer has initiated this recall to provide software corrections and updates to affected facilities including hospitals and surgical centers.
If the software provides inaccurate measurements for stent placement, a surgeon may incorrectly position a graft inside a patient's vessel. This misalignment can block critical blood flow and lead to serious internal tissue damage or complications during or after the procedure.
Includes Service Packs 10.6 SP1, SP2, SP3, SP4 and 10.7 SP1.
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.