International safety notice
A customer (outside of Japan) has reported that SpCO measurements were higher than expected in patients with abnormal COHb values. I got it. It was found that the measured O values appeared high in the range of 5-6%. Due to the above reasons, we will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Sep 20, 2022
Key facts
| Title | A customer (outside of Japan) has reported that SpCO measurements were higher than expected in patients with abnormal COHb values. I got it. It was found that the measured O values appeared high in the range of 5-6%. Due to the above reasons, we will carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Reusable Pulse Oximeter Probe Sales name: rainbow Super DCI-mini sensor |
| Manufacturer | Masimo Japan Co., Ltd. |
| Models | 20KCF, 20FFP |
| Date | Sep 20, 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