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Medical Device

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and env

Recall date: 2026-10-14 · Source: FDA_DEVICE
Brand / Firm
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 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.
Units affected
58 systems
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
View official recall notice →