International safety notice
The manufacturer has informed us that some production lots contained hose components that could expand due to gas pressure. Since we received notification that the issue has been confirmed, we have decided to voluntarily recall all affected lots that have already been shipped.
Japan / PMDA Recalls · JPN · Nov 16, 2023
Key facts
| Title | The manufacturer has informed us that some production lots contained hose components that could expand due to gas pressure. Since we received notification that the issue has been confirmed, we have decided to voluntarily recall all affected lots that have already been shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac cryosurgery unit Brand name: AtriCure Cryo Ablation System |
| Manufacturer | Century Medical Co., Ltd. |
| Models | 131600, A001056 |
| Date | Nov 16, 2023 |
| 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