I.T.S. Pelvic Reconstruction System Recall - MRI Safety

I.T.S. GmbH initiated a Class II medical device recall for its Pelvic Reconstruction System (PRS RX and PRS Phoenix) after revised MRI safety testing demonstrated that radiofrequency-induced temperature increases exceed values previously stated in the product Instructions for Use under certain MRI conditions. The recall affects multiple article numbers distributed nationally across the United States.\n\nHealthcare facilities that have implanted or stock these devices must update their MRI safety protocols and communicate the revised heating parameters to patients and clinical staff. Facilities performing MRI scans on patients with implanted Pelvic Reconstruction System devices should review the updated IFU before proceeding with imaging. The recall is classified as ongoing with an effective date of April 1, 2026.