CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

IntelliVue MX40 Patient Monitor recalled by Philips Electronics North

Philips Electronics North America is recalling IntelliVue MX40 Patient Monitor, distributed in 52 states. The recall was initiated on 30 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll devices since release of B.05 (March 2016) prefix date code >/= US096

Quantity recalled7,178

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-2142-2018
FDA event ID: 80064
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Apr 2018
FDA classified: 11 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

30 Apr 2018	Recall initiated by company
11 Jun 2018	Classified by FDA	+42 days
20 Jun 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Five warning statements are missing from the instructions for use.

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, Software Versions B.05, B.06, B.06.5X, Model 865351

Where it was distributed

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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Five warning statements are missing from the instructions for use.

Which lots are affected?

All devices since release of B.05 (March 2016) prefix date code >/= US096

Where was it sold?

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 80064

This product is part of a recall event; the main page for the event is IntelliVue MX40 Patient Monitor recalled by Philips Electronics North.

Reported	Class	Recall	Company	Reason	Where
20 Jun 2018	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	52 states
20 Jun 2018	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	52 states
20 Jun 2018	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	52 states

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All 160

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Device	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide
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3 Oct 2018Device	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
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