Health Products

Hexavue Focus Integrated System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Hexavue Focus Integrated System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Hexavue Focus Integrated SystemSN: RL26028062XEHFBU1
Hexavue Focus Integrated SystemSN: RL26063007XEHFBU1

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.

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