Food, drugs, devices › Philips North America Llc
Device recall: IntelliVue MP2. Product Number: M8102A.
Philips North America Llc (Cambridge, MA) initiated this device recall on 31 Oct 2025; FDA lists 22 product records under event 97917, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips North America Llc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America Llc, Cambridge, MA.
Reason for recall
"Potential issue where the IntelliVue monitors did not alarm."
Distribution
"Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0849-2026 | IntelliVue MP2. Product Number: M8102A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0850-2026 | IntelliVue MP5. Product Number: M8105A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0851-2026 | IntelliVue MP20. Product Number: M8001A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0852-2026 | IntelliVue MP30. Product Number: M8002A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0853-2026 | IntelliVue MP40. Product Number: M8003A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0854-2026 | IntelliVue MP50. Product Number: M8004A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0855-2026 | IntelliVue MP60. Product Number: M8005A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0856-2026 | IntelliVue MP70. Product Number: M8007A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0857-2026 | IntelliVue MP80. Product Number: M8008A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0858-2026 | IntelliVue MP90. Product Number: M8010A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0859-2026 | IntelliVue Multi Measurement Server X2. Product Number: M3002A. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0860-2026 | IntelliVue Multi-Measurement Module X3. Product Number: 867030. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0861-2026 | IntelliVue Patient Monitor MX100. Product Number: 867033. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0862-2026 | IntelliVue Patient Monitor MX400. Product Number: 866060. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0863-2026 | IntelliVue Patient Monitor MX450. Product Number: 866062. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0864-2026 | IntelliVue Patient Monitor MX500. Product Number: 866064. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0865-2026 | IntelliVue Patient Monitor MX550. Product Number: 866066. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0866-2026 | IntelliVue Patient Monitor MX600. Product Number: 865242. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0867-2026 | IntelliVue Patient Monitor MX700. Product Number: 865241. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0868-2026 | IntelliVue Patient Monitor MX750. Product Number: 866471. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0869-2026 | IntelliVue Patient Monitor MX800. Product Number: 865240. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0870-2026 | IntelliVue Patient Monitor MX850. Product Number: 866470. | 1,913,441 units | Class II | Ongoing | 10 Dec 2025 |
Context
Other enforcement events for Philips North America Llc
All 129 events for Philips North America Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential issue where the IntelliVue monitors did not alarm."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.