Health product recall

Hexavue Focus Integrated System

Last updated

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:
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
Identification number
RA-82697

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