International safety notice
It was confirmed that an error related to the pressure sensor was displayed on the operation screen and suction was stopped. We will implement a voluntary recall for lots where the possibility of a similar event occurring cannot be ruled out.
Japan / PMDA Recalls · JPN · Nov 16, 2023
Key facts
| Title | It was confirmed that an error related to the pressure sensor was displayed on the operation screen and suction was stopped. We will implement a voluntary recall for lots where the possibility of a similar event occurring cannot be ruled out. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electric low pressure suction device Sales name: Servo drain compact |
| Manufacturer | SB Kawasumi Co., Ltd. |
| Models | 30868032, 30868055, 30868054, 30868050, 30968018, 30968016, 30868057, 30968017, 30868063, 30868062, 30968015, 30968019 and 3 more |
| Date | Nov 16, 2023 |
| 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