Generic Name: Cardiovascular Ultrasound Imaging System — Trade Name: Avvigo System

Recalling firm: Name of Manufacturer and Distributor: Boston Scientific Japan K.K. — Address of Manufacturer and Distributor: Nakano Central Park South, 4-10-2 Nakano, Nakano-ku, Tokyo — Type of License: Class I...
Product: Lot: 品番：H7492493220C0 シリアル：102991580 102991581 103044290 103044291 103044574 103044577 103045130 103045131 103046258 103049557 103049558 103082231 103082236 103083046 103138555 103138559 103161660 103161661 103162802 103163114 103163116 103163310 103163312 103426739 103426983 103427062 103427064 103460619 103460621 103460622 103460623 103542656 103545307 103545308 103552891 103554558 103554562 103565448 103565449 103578369 103648168 103648304 103649576 103652219 103652220 103652529 103652531 103679278 103679281 103679467 103679469 103679552 103679554 103680003 103680004 103683853 103683854...
Reason: When using the AVVIGO System (hereinafter referred to as “this product”) in combination with the AVVIGO+ Multimodality Guidance System and the Opticross 18 Ultrasound Imaging Catheter (Approval No.: 22800BZX00278000), it was discovered that when either Live Mode or Record Mode is selected, only 9 grid marks appear on the short-axis image instead of the expected 15 (hereinafter referred to as “this issue”). Consequently, we have been providing information regarding this matter since September 2024. We have now developed software to correct this issue, and as preparations for its...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/07b39bc5-f02d-43a2-a053-d5b10c91c060