Drug recall
IntelliBridge EC10 Module. Model Number: 865115
FDA recall event 96138 · Class II · Philips North America Llc
Key facts
| Event ID | 96138 |
|---|---|
| Recall numbers | Z-1106-2025, Z-1107-2025, Z-1108-2025, Z-1109-2025, Z-1110-2025 |
| Recalling firm | Philips North America Llc |
| Product type | Devices |
| Products | IntelliBridge EC10 Module. Model Number: 865115, IntelliVue Patient Monitor MX400. Model Number: 866060, IntelliVue Patient Monitor MX450. Model Number: 866062, IntelliVue Patient Monitor MX500. Model Number: 866064, IntelliVue Patient Monitor MX550. Model Number: 866066 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board. |
| Initiation date | Jan 15, 2025 |
| Report date | Feb 12, 2025 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3016618143 |
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: