International safety notice
The catheter and ultrasound images displayed on the screen when this product is connected to the combined device "BioSense CARTO 3" We have received a report that the orientation icon is rotating irregularly. As it was discovered that calibration had been carried out during the manufacturing of the affected products, a voluntary recall of the affected products was implemented. That's what I said.
Japan / PMDA Recalls · JPN · May 12, 2022
Key facts
| Title | The catheter and ultrasound images displayed on the screen when this product is connected to the combined device "BioSense CARTO 3" We have received a report that the orientation icon is rotating irregularly. As it was discovered that calibration had been carried out during the manufacturing of the affected products, a voluntary recall of the affected products was implemented. That's what I said. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Central circulatory system intravascular ultrasound catheter Sales name: Sound Star SH |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | E8358015, G9227268, E8357961, E8358026, E8357977, G9227288, E8357980, G9227270, G9227286, E8357946, E8357963, G9227049 and 261 more |
| Date | May 12, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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