Steris HexaVue Focus Integration System Recalled for Patient Data Mismatch
Steris is recalling 58 HexaVue Focus Integration Systems because a software issue may cause incorrect patient information to appear on printed images.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a software issue that may cause documentation discrepancies or incorrect association of clinical images with patient records. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 58 units of the HexaVue Focus Integration System, Software Version 2.0.18. This system is used for operating room video routing, surgical video integration, and environmental control. The recall is due to a software issue that may result in an unintended mismatch of patient information on manually printed images.
Incorrect patient information appearing on printed images could create a documentation discrepancy or an incorrect association of clinical images with a patient record. The affected systems were distributed in the United States, Australia, Canada, and New Zealand.
Healthcare facilities should contact Steris Corporation for instructions on how to resolve the software issue. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- 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
- Manufacturer
- Steris Corporation
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI: 00724995245047
Distribution
Distributed nationwide across the United States.
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