CLASS II Device recall · Reported 2 Jun 2021 · FDA Enforcement Report
IntelliVue MX40 Patient Monitor recalled by Philips North America
Philips North America is recalling IntelliVue MX40 Patient Monitor, distributed nationwide in the US. The recall was initiated on 2 Feb 2021 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-1671-2021
- FDA event ID
- 87829
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Feb 2021
- FDA classified
- 21 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 2 Feb 2021 | Recall initiated by company | |
| 21 May 2021 | Classified by FDA | +108 days |
| 2 Jun 2021 | 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
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
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, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Questions about this recall
Why was it recalled?
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Which lots are affected?
Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
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.
More recalls from Philips North America
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|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Cardiac Workstation recalled by Philips North America | Philips North America | Labeling Errors | Nationwide |
Other Patient Monitors recalls
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 |