Z-0544-2021Class II

Philips IntelliVue X2 Multi measurement Server: M3002A (865039) -

Name: Z-0544-2021 Philips IntelliVue X2 Multi measurement Server: M3002A (865039) -
Creator: Philips North America Llc
Published: 2020-11-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-11-18 / Terminated / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple... on 2020-11-18. FDA classified it as Class II and gives the reason as "Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0544-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-18
Posted: 2020-12-08
Terminated: 2021-07-22
Recalling firm: Philips North America LLC
Product: Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Philips is asking users to follow the Action to be Taken by Customer/User section of the FSN: Affected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the Speaker Malfunct. INOP at power-up. If you experience this INOP or there is no sound from your X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative Philips representative or Philips Customer Support at 1-800-722-9377 Please complete the attached Reply Card and return it to Philips as soon as possible. Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative will contact you to arrange for the replacement of the speaker assembly in the listed affected devices.
Quantity in commerce: 16 total: 2 units US ; 14 OUS
Distribution: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Product codes and lots: Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE73601727 DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0544-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0544-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-08
Z-0545-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-08

Product code DSI

K082633Class IIIntellivue Patient Monitor, Intellivue Xds, Models Mp2, Mp5, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2008-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)