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Avvigo™+ multi-modality guidance system

Official notice

18 Dec 2024

MediumHealth Canada

An official Health Canada notice concerns Avvigo™+ multi-modality guidance system. On November 25th, 2024, BSC notified users of a potential software anomaly that can occur when the Avvigo+ Multi-Modality Guidance System is connected to an OptiCross 18 Imaging Catheter. When in live or record mode, the grid mark overlay on cross-sectional view would not display correctly. This advisory is to inform customers of a software update to correct this anomaly. Recall start date: November 18, 2024 Published 2024-12-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76712

Official notice

2024-12-18

The hazard

On November 25th, 2024, BSC notified users of a potential software anomaly that can occur when the Avvigo+ Multi-Modality Guidance System is connected to an OptiCross 18 Imaging Catheter. When in live or record mode, the grid mark overlay on cross-sectional view would not display correctly. This advisory is to inform customers of a software update to correct this anomaly. Recall start date: November 18, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76712

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Affected products

Product 1

Affected products - AVVIGO™ + Mobile System, Lot or serial number - All lots., Model or catalog number - H7492493120C0

Product 2

Affected products - AVVIGO™ + Integrated System, Lot or serial number - All lots., Model or catalog number - H7492493120I0

Product 3

Affected products - AAVVIGO™ + Mobile Evaluation System, Lot or serial number - All lots., Model or catalog number - H7492493120D0

Risk / hazard

On November 25th, 2024, BSC notified users of a potential software anomaly that can occur when the Avvigo+ Multi-Modality Guidance System is connected to an OptiCross 18 Imaging Catheter. When in live or record mode, the grid mark overlay on cross-sectional view would not display correctly. This advisory is to inform customers of a software update to correct this anomaly. Recall start date: November 18, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Avvigo™+ Multi-modality Guidance System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76712

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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