FDA-Device2026-10-14Class IIPROCESSING DEFECT
Steris HexaVue Focus Integration System software issue may print incorrect patient information
What this means
A software issue in Steris HexaVue Focus Integration System (version 2.0.18) can cause incorrect patient information to appear on manually printed surgical images. This mismatch could lead to documentation errors or clinical images being linked to the wrong patient record.
- If you operate this system, contact Steris immediately for guidance on the software issue
- Do not rely on printed images from this system version until you receive updated instructions from Steris
- Review any printed images from affected systems to verify patient information matches the intended patient
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Affected count
58 systems
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2027More Steris recalls
- FDA-Device2026-10-14Steris VERIFY Biological Steam Test Pack recalled for inadequate spore population
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for insufficient spore population
- FDA-Device2026-10-14Steris VERIFY Dual Species Biological Indicator recalled for unreliable spore population
- FDA-Device2026-10-14Steris VERIFY Dual Species Biological Indicator recalled for insufficient spore population
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for inadequate spore population
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