CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
IntelliVue Patient Monitor MX500 recalled by Philips North America
Philips North America is recalling IntelliVue Patient Monitor MX500, distributed in Florida, North Carolina. The recall was initiated on 15 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1109-2025
- FDA event ID
- 96138
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jan 2025
- FDA classified
- 5 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 15 Jan 2025 | Recall initiated by company | |
| 5 Feb 2025 | Classified by FDA | +21 days |
| 12 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IntelliVue Patient Monitor MX500. Model Number: 866064
Where it was distributed
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number: 866064. UDI-DI: (01)00884838038776(21); Serial Numbers: DE7580A1R5, DE7580A1R4, DE7580A1R1, DE7580A1R0, DE7580A1PM, DE7580A1PL, DE7580A1PK, DE7580A1PJ, DE7580A1P5, DE351C8913, DE351C8912, DE351C8908, DE351C8911, DE351C8910, DE351C8909, DE32300881, DE32300882, DE32300883, DE32300937, DE32300936, DE32301099, DE35114607, DE35114606, DE671T0786, DE671K1669, DE671V9213, DE35133301, DE671N0625, DE671E0967, DE671E0964, DE671E0965, DE671E0968, DE671E0978, DE671E1009, DE671E1008, DE671E1007, DE671E1006, DE671E1005, DE671E1004, DE671E0977, DE671E1003, DE671E0979, DE671E1015, DE671E0966, DE671E1059.
Where was it sold?
US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96138This product is part of a recall event; the main page for the event is IntelliVue Patient Monitor MX400 recalled by Philips North America.
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|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |