HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video
Summary
The FDA issued a Class II for HexaVue Focus Integration System, a single, all-in-one system that handles opera by Steris Corporation. Reason: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on print.
Details
Source
Device Recall
External ID
Z-0118-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product 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
Lot/Code Info: 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
Quantity Affected: 58 systems
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.
Distribution
Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-23
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Steris Corporation has 74 FDA actions in our database, including 35 recalls and 39 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 74 FDA actions in our database, including 35 recalls and 39 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0118-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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