HexaVue Focus Integration System Recall: Software Issue
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was HexaVue Focus Integration System recalled?
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 should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Lot Code: UDI: 00724995245047; Serial Numbers: RL25293001 RL25301003 RL25301004 RL26007031 RL26013044 RL26013045 RL26028062 RL26040066 RL26054029 RL26062001 RL26063005 RL26063007 RL26063013 RL26063014 RL26063019 RL26063021 RL26063022 RL26063023 RL26069033 RL26069034 RL26072049 RL26072052 RL26072053 RL26072055 RL26072056 RL26072056 RL26077072 RL26077073 RL26077074 RL26083077 RL26084078 RL26084080 RL26084081 RL26085083 RL26085084 RL26085085 RL26085086 RL26085087 RL26085088 RL26085089 RL26089090 RL26089091 RL26089092 RL26089093 RL26089094 RL26089095 RL26089096 RL26089097 RL26098098 RL26104099 RL26105102 RL26133103 RL26133104 RL26138105 RL26139106 RL26140114 RL26187116 RL26243121
- Agency record number
- Z-0118-2027
- Product
- HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental…
- Recalling firm
- Steris Corporation
- Quantity
- 58 systems
- Distribution
- Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
- Recall started
- September 23, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)