International safety notice
Masimo allows certain Masimo SET Rad-G series (hereinafter referred to as Rad-G) to be turned on or off without pressing the power button. I have confirmed that it will be FF. We have confirmed the problem and have decided to recall it.
Japan / PMDA Recalls · JPN · Apr 30, 2024
Key facts
| Title | Masimo allows certain Masimo SET Rad-G series (hereinafter referred to as Rad-G) to be turned on or off without pressing the power button. I have confirmed that it will be FF. We have confirmed the problem and have decided to recall it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulse oximeter Sales name: Masimo SET Rad-G series |
| Manufacturer | Masimo Japan Co., Ltd. |
| Models | 6000080991, 6000080369, 6000073630, 6000074300, 6000081244, 6000080211, 6000081117, 6000075805, 6000081163, 6000080734, 6000075263, 6000075932 and 1226 more |
| Date | Apr 30, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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