AVVIGO+ Medical Imaging System Grid Overlay Display Software Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical imaging device with a software display anomaly that could affect clinical measurements. No patient injuries or illnesses have been reported; however, the incorrect grid overlay during Live and Record modes poses a risk to proper clinical assessment during cardiovascular procedures.
Plain-English summary
Boston Scientific AVVIGO+ Multi-Modality Guidance System is a medical device that displays physiologic, intravascular, and intracardiac anatomical information to physicians during cardiac and vascular procedures. This recall affects 5 units with specified serial numbers (104877663, 104883563, 104890983, 104895226, 105036836) that were distributed in the U.S. and Puerto Rico.
A software anomaly causes the grid mark overlay on the cross-sectional imaging view to display incorrectly when an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system during Live or Record mode. The system displays a 9-grid overlay instead of the correct 15-grid overlay, which should allow for reference depth settings of 14.9mm for peripheral catheters. In Review mode, the system displays the correct 15-grid overlay and vessel images at the appropriate scale.
No patient injuries or illnesses have been reported in association with this recall.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-anomaly
- display-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Material Number H7492493320CZ0
- GTIN/UDI/DI 00191506033323
- Batch/Serial Numbers: 104877663
- 104883563
- 104890983
- 104895226
- 105036836
Distribution
Distributed nationwide across the United States.
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