Recall Z-0118-2027— Steris Corporation
Class II · Ongoing
Class II FDA medical device recall by Steris Corporation, initiated 2026-09-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-23
- Firm location
- Mentor, OH, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.