International safety notice
Although the foreign manufacturer responsible for the design and the foreign manufacturer responsible for the main assembly of this device have changed, Products that have not been registered and have not undergone a QMS compliance survey and whose certification details differ from those of the medical device in question are being distributed in Japan. Due to this, we will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 13, 2024
Key facts
| Title | Although the foreign manufacturer responsible for the design and the foreign manufacturer responsible for the main assembly of this device have changed, Products that have not been registered and have not undergone a QMS compliance survey and whose certification details differ from those of the medical device in question are being distributed in Japan. Due to this, we will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Blood pressure pulse wave testing device Sales name: SIGMO Core XCEL TM-2805 |
| Manufacturer | A&D Co., Ltd. |
| Models | 2A7500139, 2A7500140 |
| Date | May 13, 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