CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

IntelliVue Patient Monitor MX550 with L.x and M.x recalled

Philips North America is recalling IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements, distributed nationwide in the US. The recall was initiated on 28 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00884838038783

Quantity recalled9 units US

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-2511-2024
FDA event ID: 94919
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jun 2024
FDA classified: 5 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

28 Jun 2024	Recall initiated by company
5 Aug 2024	Classified by FDA	+38 days
14 Aug 2024	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

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,

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 Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

Where it was distributed

Nationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China Colombia Denmark France Germany Hong Kong India Indonesia Italy Japan Netherlands Portugal Singapore South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand United Kingdom Vietnam

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 00884838038783

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 94919

This product is part of a recall event; the main page for the event is IntelliVue Patient Monitor MX500 with L.x and M.x recalled.

Reported	Class	Recall	Company	Reason	Where
14 Aug 2024	CLASS II	IntelliVue Patient Monitor MX500 with L.x and M.x recalled	Philips North America	Device Malfunction	Nationwide
14 Aug 2024	CLASS II	IntelliVue Patient Monitor MX400 with L.x and M.x recalled	Philips North America	Device Malfunction	Nationwide
14 Aug 2024	CLASS II	IntelliVue Patient Monitor MX450 with L.x and M.x recalled	Philips North America	Device Malfunction	Nationwide

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