Drug recall
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
FDA recall event 94170 · Class II · Masimo Corporation
Key facts
| Event ID | 94170 |
|---|---|
| Recall numbers | Z-1536-2024, Z-1537-2024, Z-1538-2024, Z-1539-2024 |
| Recalling firm | Masimo Corporation |
| Product type | Devices |
| Products | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,, Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,, Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,, Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| Initiation date | Feb 15, 2024 |
| Report date | Apr 24, 2024 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3011353843 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: