Z-0854-2016Class II

Philips IntelliVue Module Measurement X2 Model: M3002A

Name: Z-0854-2016 Philips IntelliVue Module Measurement X2 Model: M3002A
Creator: Philips Electronics North America Corporation
Published: 2016-01-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-01-04 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips IntelliVue Module Measurement X2 Model: M3002A on 2016-01-04. FDA classified it as Class II and gives the reason as "The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0854-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-04
Posted: 2016-02-23
Terminated: 2021-03-01
Recalling firm: Philips North America LLC
Product: Philips IntelliVue Module Measurement X2 Model: M3002A
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
Root cause tag: software
FDA root cause: Software Design Change
Action: Philips Healthcare issued the Field Safety Notice on January 4, 2016, and informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Until your software is upgraded, please make sure that the ST Analysis is switched ON when using STE measurement in the Hexad 12-lead ECG Monitoring. This can be done by entering the ST Analysis Menu and select ST Analysis to On. For more detailed information, please refer to the Instructions for Use (IFU) of your host monitor or to the X2 Measurement Module IFU. Philips will provide a software correction free of charge. For further questions please call (978) 659-3000.
Quantity in commerce: 13,300
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Product codes and lots: Software Revision: K.21.54 or L.00.96

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0854-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0853-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23
Z-0854-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

Product code MHX

K150310Class IIIntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH / cleared 2015-05-13

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)