Drug recall
IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use…
FDA recall event 81531 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 81531 |
|---|---|
| Recall numbers | Z-0592-2019 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished… |
| Initiation date | Oct 10, 2018 |
| Report date | Dec 19, 2018 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 1–9 Products in this recall
- None 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: