International safety notice
Because the manufacturing industry registration of the design and manufacturing facility listed on the standard conformity certificate had not been updated, the manufacturing company with design responsibility was recognized for certification purposes. The company did not have a regular QMS compliance survey, and it was different from the manufacturing site (storage of final products) on the certificate. The affected products will be recalled because they were manufactured at a manufacturing facility.
Japan / PMDA Recalls · JPN · Dec 26, 2024
Key facts
| Title | Because the manufacturing industry registration of the design and manufacturing facility listed on the standard conformity certificate had not been updated, the manufacturing company with design responsibility was recognized for certification purposes. The company did not have a regular QMS compliance survey, and it was different from the manufacturing site (storage of final products) on the certificate. The affected products will be recalled because they were manufactured at a manufacturing facility. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Program for sleep assessment devices Sales name: SAS inspection program for Simon.J |
| Manufacturer | Yamori Electronic Device Co., Ltd. |
| Models | H00078, H00021, H00090, H00017, H00070, H00101, H00250, H00088, H00032, H00035, H00098, H00009 and 29 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