CFIA - Canadian Food Inspection Agency
CFIA - Canadian Food Inspection Agency
10/02/2026 | Press release | Distributed by Public on 10/02/2026 09:38
Hexavue Focus Integrated System
Health product recall
Hexavue Focus Integrated System
Brand(s)
Last updated
2026-10-02
Summary
Product
Hexavue Focus Integrated System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
|
Affected products |
Lot or serial number |
Model or catalogue number |
|
Hexavue Focus Integrated System |
SN: RL26028062 |
XEHFBU1 |
|
Hexavue Focus Integrated System |
SN: RL26063007 |
XEHFBU1 |
Issue
A software issue may result in unintended mismatch of patient information on manually printed images. During an active procedure, a user may manually select a different patient record from the "Patient Cases" menu and subsequently manually print images ("Manual Print Workflow"). In this specific Manual Print Workflow, the printed output may display patient identifying information from the selected patient record rather than the active procedure, including patient name, date of birth and medical record number (MRN).The image displayed is the image intended for the procedure; however, the printed image may contain incorrect patient identifiers. Auto-Print functionality is not impacted.
Additional information
Details
Original published date: 2026-10-02
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Steris Corporation
2720 Gunter Park East, Montgomery, Alabama, United States, 36109
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
2026-09-09
Identification number
RA-82697
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Date modified: 2026-10-02
CFIA - Canadian Food Inspection Agency published this content on October 02, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on October 02, 2026 at 15:38 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]