Public recall detail

Hexavue Focus Integrated System

2026-10-02

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Health products Health product recall
Quick summary

Quick summary: Hexavue Focus Integrated System. Reason: Health product recall. Category: Health products. Date: 2026-10-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hexavue Focus Integrated System. Reason: Health product recall. Category: Health products. Date: 2026-10-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSteris Corporation
ProductHexavue Focus Integrated System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82697

Affected products

ProductHexavue Focus Integrated System
LotSN: RL26028062
ModelXEHFBU1
Serial numberSN: RL26028062
DescriptionHexavue Focus Integrated System
ProductHexavue Focus Integrated System
LotSN: RL26063007
ModelXEHFBU1
Serial numberSN: RL26063007
DescriptionHexavue Focus Integrated System

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesSteris Corporation 2720 Gunter Park East, Montgomery, Alabama, United States, 36109
Recall date2026-09-09
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82697
Background{}
CompaniesSteris Corporation 2720 Gunter Park East, Montgomery, Alabama, United States, 36109
AudiencesHealthcare
Source updated2026-10-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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