International safety notice
Regarding this product, we have received a report that a crack has occurred in a specific part of the housing component, so an investigation has been conducted at the overseas manufacturer. However, when the resin part was molded, a small void was formed inside, and cracks appeared in the area over time. It turns out that there is a possibility. I decided to do so.
Japan / PMDA Recalls · JPN · Jun 11, 2024
Key facts
| Title | Regarding this product, we have received a report that a crack has occurred in a specific part of the housing component, so an investigation has been conducted at the overseas manufacturer. However, when the resin part was molded, a small void was formed inside, and cracks appeared in the area over time. It turns out that there is a possibility. I decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ultrasonic suction device Product name: Ultrasonic surgical instrument CUSA EXcel |
| Manufacturer | Integra Japan Co., Ltd. |
| Models | HAM1603902IE, HAK2002202IE, HAK1607502IE, HAK1704102IE, HAH1605602IE, HAE1708302IE, HAL2000602IE, HAB1706402IE, HAG1902702IE, HAC1909602IE, HAA1704302IE, HAL1700602IE and 240 more |
| Date | Jun 11, 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