Device Class II · moderate Ongoing Oct 14, 2026

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.

Recalling firm	Steris Corporation
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.
Risk class	Class II (Class II · moderate)
Status	Ongoing
Report date	Oct 14, 2026
Initiated	Sep 23, 2026
Region	OH, United States
Distribution	Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Quantity	58 systems
Code/Lot	Lot Code: UDI: 00724995245047; Serial Numbers: RL25293001 RL25301003 RL25301004 RL26007031 RL26013044 RL26013045 RL26028062 RL26040066 RL26054029 RL26062001 RL26063005 RL26063007 RL26063013 RL2606301…
Type	Voluntary: Firm initiated
Recall number	Z-0118-2027

Official source

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