Recall archive / FDA device enforcement
IntelliVue Patient Monitor MX400. Model Number: 866060 — FDA record Z-1107-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- IntelliVue Patient Monitor MX400. Model Number: 866060
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 28 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1107-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 12, 2025
- Recall initiation date
- Jan 15, 2025
- Center classification date
- Feb 5, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.