Z-0292-2018Class II

IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement...

Name: Z-0292-2018 IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement...
Creator: Philips Electronics North America Corporation
Published: 2017-08-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-08-23 / Open, Classified / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2... on 2017-08-23. FDA classified it as Class II and gives the reason as "Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0292-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-08-23
Posted: 2017-12-27
Recalling firm: Philips North America LLC
Product: IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
Root cause tag: software
FDA root cause: Software design
Action: Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative.
Quantity in commerce: 7071
Distribution: Worldwide Distribution and US Nationwide
Product codes and lots: Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0292-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-03	2017-12-27

Product code MHX

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)