Skip to content

IntelliVue Patient Monitor MX550

by Philips Medizin Systeme Böblingen GmbH

Ref 866066

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192137↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM589TV Basic UDI-DI 00884838038783UDI-DIDate30 Apr 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK192137 Date11 Sep 2020IssuedStatusActive
United StatesGUDID listing GUDID Number00884838038783 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0864-2026 FDA Class II initiated 31 Oct 2025
    • Ongoing Z-0865-2026 FDA Class II initiated 31 Oct 2025

    Potential issue where the IntelliVue monitors did not alarm.

    • Ongoing Z-3249-2024 FDA Class II initiated 30 Aug 2024

    During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

    • Ongoing Z-0020-2025 FDA Class II initiated 14 Jun 2023

    Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.

    • Terminated Z-2328-2016 FDA Class II initiated 26 Jul 2016

    If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
IntelliVue Patient Monitor MX550 EUDAMED
IntelliVue MX550 Patient Monitor GUDID
Generic Name
Multiple vital physiological parameter monitoring system, clinical
Device Name
MX400-550
Model / Ref / Catalog
866066, IntelliVue Patient Monitor MX550
Primary DI / UDI-DI
00884838038783
Basic UDI-DI
0884838BM589TV
Direct Marketing DI
00884838038783
FDA Product Code
MHX
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
Multiple vital physiological parameter monitoring system, clinical
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
866066
GUDID
IntelliVue Patient Monitor MX550
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

See all devices from Philips Medizin Systeme Böblingen GmbH →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No