Steris recalls HexaVue Focus Integration System, a single, all-in-one system that handles…
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the 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.
What's affected
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
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