FDAFDA · Food and drugs·Recall number Z-1110-2025
IntelliVue Patient Monitor MX550. Model Number: 866066
Published February 12, 2025 · Recall initiated: January 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
- Lot
- Model Number: 866066. UDI-DI: (01)00884838038783(21); Serial Numbers: DE671E3020, DE671E2989, DE671E2988, DE671E3086, DE671E3085, DE671E3084, DE671E3097, DE671E3096, DE671E3095, DE671E3094, DE671E3093, DE671E3253, DE671E3246, DE671E3245, DE671E3244, DE671E3241, DE671E3240, DE671E3234, DE671E3235, DE671E3238, DE671E3239, DE671E3021, DE671E3236, DE671E3865, DE671E3863, DE671E3862, DE671E3861, DE671E3860, DE671E3859, DE671E3858, DE671E3857, DE671E3856, DE671E3855, DE671E3853, DE671E3852, DE671E3867, DE671E3871, DE671E3730, DE671E3729, DE671E3866, DE35186967, DE35186949, DE35186948, DE35186947, DE35186944, DE35186943, DE35186942, DE35186941, DE35186940, DE35186939, DE35186938, DE35186982, DE35186945, DE35199396, DE35199398, DE35199428, DE671E2030, DE671H1334, DE32302561, DE32302562, DE32301002, DE32301003, DE32301004, DE35114609, DE35114608, DE758Y7635, DE758Y7616, DE758Y7619, DE758Y7615, DE758Y7614, DE7580AWK6, DE7580AWK7, DE7580AWKB, DE7580AWK4.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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