AVVIGO™+ Multi-Modality Guidance System
Brand(s)
Last updated
Summary
Product
AVVIGO™+ Multi-Modality Guidance 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 catalog number |
|---|---|---|
| AVVIGO™ + Mobile System | All lots. | H7492493120C0 |
| AVVIGO™ + Integrated System | All lots. | H7492493120I0 |
| AAVVIGO™ + Mobile Evaluation System | All lots. | H7492493120D0 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76712
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