International safety notice
A report from a medical institution that an error message appears on the monitor screen of this product when using the SPU, which is a component of this product. has been accepted. We have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Nov 7, 2022
Key facts
| Title | A report from a medical institution that an error message appears on the monitor screen of this product when using the SPU, which is a component of this product. has been accepted. We have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac catheter testing device Sales name: Biosense CARTO 3 |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | S434088, KTS430482, S436298, S434112, EM507000F, KTS436298, KTS436297, KTS434116, KTS430513, S434115, S436297, KTS434141 and 18 more |
| Date | Nov 7, 2022 |
| 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