CLASS II ONGOING Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
IntelliVue MX40 Patient Monitor, Product number recalled
Philips North America is recalling IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531, distributed nationwide in the US. The recall was initiated on 28 Mar 2019 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-1695-2019
- FDA event ID
- 82696
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2019
- FDA classified
- 31 May 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 28 Mar 2019 | Recall initiated by company | |
| 31 May 2019 | Classified by FDA | +64 days |
| 12 Jun 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
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 MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Where it was distributed
Worldwide distribution - US Nationwide and to 71 countries.
Questions about this recall
Why was it recalled?
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Which lots are affected?
All revision B.X versions are affected.
Where was it sold?
Worldwide distribution - US Nationwide and to 71 countries.
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
3 other products · FDA event 82696This product is part of a recall event; the main page for the event is IntelliVue MX40 Patient Monitor, Product number recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IntelliVue MX40 Patient Monitor, Product number recalled | Philips North America | Device Malfunction | Nationwide | |
| CLASS II | IntelliVue MX40 Patient Monitor, Product number recalled | Philips North America | Device Malfunction | Nationwide | |
| CLASS II | IntelliVue MX40 Patient Monitor, Product number recalled | Philips North America | Device Malfunction | Nationwide |
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All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |