Steris Corporation: Hexavue Focus Integration System, A Single, All-in-one System That Handles Operating Room Video Routing, Surgical Video Integration, And Environmen...
Recall Summary Steris Corporation is recalling the HexaVue Focus Integration System (Software Version 2.0.18), an operating room device that manages video routing and environmental controls. A software problem can cause patient information printed on surgical images to be mismatched or incorrect, potentially linking images to the wrong patient's medical record. The recall affects devices distributed nationwide in the US and in Australia, Canada, and New Zealand.
- Recalling firm
- Steris Corporation
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-23
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/5be888a1-afa8-4962-82c7-8a4fef0f4b13