International safety notice
The M-LNCS reusable sensor TC-I manufactured and sold by our company. It has been reported that the SpO2 measurement value using the Bull Sensor TC-I ear fluctuates unexpectedly and falls outside the specification range (measurement accuracy). Ta. Masimo research shows that TCI sensors have a high variation of 4.4% across Arms, compared to the specified value of 3.5% Arms. It turns out that there is. Although we have not received any reports of health hazards from medical institutions in Japan or overseas, we cannot rule out the possibility that the affected products were shipped to the market. Because of this, we have decided to begin collection.
Japan / PMDA Recalls · JPN · Nov 20, 2023
Key facts
| Title | The M-LNCS reusable sensor TC-I manufactured and sold by our company. It has been reported that the SpO2 measurement value using the Bull Sensor TC-I ear fluctuates unexpectedly and falls outside the specification range (measurement accuracy). Ta. Masimo research shows that TCI sensors have a high variation of 4.4% across Arms, compared to the specified value of 3.5% Arms. It turns out that there is. Although we have not received any reports of health hazards from medical institutions in Japan or overseas, we cannot rule out the possibility that the affected products were shipped to the market. Because of this, we have decided to begin collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Reusable Pulse Oximeter Probe Sales name: M-LNCS, LNCS series |
| Manufacturer | Dräger Japan Co., Ltd. |
| Models | MP03099, 21GFE，21HUC，22G2E，22HSC，E20H1G，E21DYY，E21G7M, 18DCB，18ENJ，19D83，19GCV，19M11，20JLT，20NGB，20NUT，21BVK，21DFN， |
| Date | Nov 20, 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