Drug recall
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
FDA recall event 80064 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 80064 |
|---|---|
| Recall numbers | Z-2141-2018, Z-2142-2018, Z-2143-2018, Z-2144-2018 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350, IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351, IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352, IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Five warning statements are missing from the instructions for use. |
| Initiation date | Apr 30, 2018 |
| Report date | Jun 20, 2018 |
| Termination date | Oct 4, 2019 |
| 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: