International safety notice
In some lots of "Opticross Ultrasonic Imaging Catheter" (hereinafter referred to as "this product"), There is a possibility that a product that does not meet the specifications was shipped due to an error in the setting values in the manufacturing process (hereinafter referred to as "this event"). As a result, we have decided to voluntarily recall the affected lot of this product.
Japan / PMDA Recalls · JPN · Mar 5, 2024
Key facts
| Title | In some lots of "Opticross Ultrasonic Imaging Catheter" (hereinafter referred to as "this product"), There is a possibility that a product that does not meet the specifications was shipped due to an error in the setting values in the manufacturing process (hereinafter referred to as "this event"). As a result, we have decided to voluntarily recall the affected lot of this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Central circulatory system intravascular ultrasound catheter Brand name: Opticross Ultrasound Imaging Catheter |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | H749518080120, 32429407, 51808-012, 32426901, 32625286 |
| Date | Mar 5, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1