International safety notice
Medical institutions in Japan have reported multiple cases in which water leakage was detected during cleaning inspection after use of ultrasound endoscopes used in conjunction with this product. A number of cases have been reported. The manufacturer is currently investigating the cause, but as we have only received reports of this phenomenon in Japan, it is We are conducting a voluntary recall of all products shipped to our factory because we cannot deny the possibility that similar defects may occur. I decided to do so.
Japan / PMDA Recalls · JPN · Jul 20, 2022
Key facts
| Title | Medical institutions in Japan have reported multiple cases in which water leakage was detected during cleaning inspection after use of ultrasound endoscopes used in conjunction with this product. A number of cases have been reported. The manufacturer is currently investigating the cause, but as we have only received reports of this phenomenon in Japan, it is We are conducting a voluntary recall of all products shipped to our factory because we cannot deny the possibility that similar defects may occur. I decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use aspiration needle Brand name: Ultrasonic endoscopic puncture needle |
| Manufacturer | Century Medical Co., Ltd. |
| Models | 220201177, 220204171, 220103176, EUS-19-1-N, EUS-22-0-N, 220204176, EUS-19-0-N, 220204174, EUS-22-1-N, 220204172, 220103174, 220307172 and 11 more |
| Date | Jul 20, 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