HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.

An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/26 was sent to customers. User Action Users can continue to use their integration system(s) prior to completion of the correction, but should confirm that manually printed images are correctly labeled prior to clinical use, filing or scanning into a patient record, distribution or other reliance upon the printed output. Customers should consider reviewing any manually printed images generated using software version 2.0.18 if they have reason to believe the manual print workflow described in this notice may have occurred. Prior to your system(s) receiving the updated software, if you are utilizing the manual printing functionality and have questions regarding the issue described in this notice or interim mitigation measures, please contact STERIS ORI Support at [email protected], or at 800-548-4873. Users are reminded to report any adverse events via FDA s MedWatch Database or local competent authority should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers.