International safety notice
A product was shipped to the market without being approved for release to the market. Some of the shipped products may contain nonconforming products that do not meet internal standards.
Japan / PMDA Recalls · JPN · Sep 29, 2022
Key facts
| Title | A product was shipped to the market without being approved for release to the market. Some of the shipped products may contain nonconforming products that do not meet internal standards. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: automatic electronic blood pressure monitor Brand name: OMRON digital automatic blood pressure monitor HEM-1040 |
| Manufacturer | OMRON Healthcare Co., Ltd. |
| Models | 20220800337LF, 20220800263LF, 20220800385LF, 20220800398LF, 20220800372LF, 20220800331LF, 20220800397LF, 20220800352LF, 20220800374LF, 20220800335LF, 20220800376LF, 20220800354LF and 70 more |
| Date | Sep 29, 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