International safety notice
The concentration of the standard gas used for calibration was outside the standard value range. Measurement results that exceed the error range of nitric oxide (NO) concentration measurement accuracy set in the approval document are displayed. An internal investigation revealed this possibility. Therefore, we calibrated using a standard gas that was outside the standard value range. We will collect the shipped product with the relevant serial number.
Japan / PMDA Recalls · JPN · Jun 17, 2024
Key facts
| Title | The concentration of the standard gas used for calibration was outside the standard value range. Measurement results that exceed the error range of nitric oxide (NO) concentration measurement accuracy set in the approval document are displayed. An internal investigation revealed this possibility. Therefore, we calibrated using a standard gas that was outside the standard value range. We will collect the shipped product with the relevant serial number. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Nitric oxide gas analyzer Brand name: (1) Breath NO monitor NObreath (2) Breath NO monitor NObreath V2 |
| Manufacturer | Harada Sangyo Co., Ltd. |
| Models | NN006059, NN006056, NN006052, NBR025768, NN006054, NBR025069, NBR024405, NBR024159, NN006060, NN006062, NN006057, NBR025601 and 2 more |
| Date | Jun 17, 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