International safety notice
After receiving a complaint regarding accuracy from an overseas customer and analyzing it at the manufacturer, we found that other sensors manufactured and sold by Masimo We found a sensor that had a slightly higher SpO2 value. We have confirmed that the SpO2 readings of our chip clip sensor have an unexpectedly high variation outside of our accuracy specifications. Ta. A high degree of variability was found. Due to the above reasons, we will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Jul 13, 2023
Key facts
| Title | After receiving a complaint regarding accuracy from an overseas customer and analyzing it at the manufacturer, we found that other sensors manufactured and sold by Masimo We found a sensor that had a slightly higher SpO2 value. We have confirmed that the SpO2 readings of our chip clip sensor have an unexpectedly high variation outside of our accuracy specifications. Ta. A high degree of variability was found. 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: (1) Masimo SET sensor LNCS reusable sensor series (2) Masimo SET sensor LNOP TC-I/TF-I (3) Masimo SET sensor M-LNCS reusable sensor series (4) Masimo RD SET Reusable Sensor Series |
| Manufacturer | Masimo Japan Co., Ltd. |
| Models | 19KAM, 19EAJ, 20KMY, 18GNZ, 20C76, E20H1G, 22GTT, 20ABM, 22HHW, 18K48, 20NGC, 17NFD and 40 more |
| Date | Jul 13, 2023 |
| 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