International safety notice
The manufacturing site (design, main assembly) listed on the standard conformity certificate has not undergone a regular QMS conformity survey. The equipment was recalled because it was manufactured at a different manufacturing site than the one listed on the certificate (where the final product is stored). vinegar.
Japan / PMDA Recalls · JPN · Dec 26, 2024
Key facts
| Title | The manufacturing site (design, main assembly) listed on the standard conformity certificate has not undergone a regular QMS conformity survey. The equipment was recalled because it was manufactured at a different manufacturing site than the one listed on the certificate (where the final product is stored). vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: sleep assessment device Sales name: Simon.J |
| Manufacturer | Yamori Electronic Device Co., Ltd. |
| Models | 00089, 00630, 00082, UB010CBBM00014, 00674, 00657, 00098, 00311, 00307, 00387, 00201, 00342 and 204 more |
| Date | Dec 26, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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