Food, drugs, devices › Philips Electronics North America Corporation
Device recall: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
FDA enforcement event 80064 is a device recall by Philips Electronics North America Corporation of Andover, MA, initiated 30 Apr 2018 and classified Class II, with 4 product records.
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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 Oct 2019. Initiation: voluntary: firm initiated. Philips Electronics North America Corporation has 61 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 Electronics North America Corporation, Andover, MA.
Reason for recall
"Five warning statements are missing from the instructions for use."
Distribution
"Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2141-2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 | 25,499 | Class II | Terminated | 20 Jun 2018 |
| Z-2142-2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351 | 7,178 | Class II | Terminated | 20 Jun 2018 |
| Z-2143-2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 | 4,488 | Class II | Terminated | 20 Jun 2018 |
| Z-2144-2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146 | 94 | Class II | Terminated | 20 Jun 2018 |
Context
Other enforcement events for Philips Electronics North America Corporation
All 61 events for Philips Electronics North America Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Five warning statements are missing from the instructions for use."
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, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Oct 2019. "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.