Z-2626-2010

Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is...

Name: Z-2626-2010 Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is...
Creator: Philips Healthcare Inc.
Published: 2010-08-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-08-31 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters... on 2010-08-31. The reason FDA records is "Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment". 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-2626-2010
Status: Terminated
Initiated: 2010-08-31
Posted: 2010-09-29
Terminated: 2017-02-15
Recalling firm: Philips North America LLC
Product: Philips M8102A IntelliVue MP2 Model: 865040 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. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks. Affected products may continue to e 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 at 1-800-722-9377.
Quantity in commerce: 2,832 UNITS
Distribution: Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LIBYAN ARAB JAMAHIRI LITHUANIA MALAYSIA MAURITIUS MEXICO MOROCCO NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PARAGUAY POLAND PORTUGAL QATAR ROMANIA RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN THAILAND TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN and VIET NAM
Product codes and lots: Serial Number range: DE83604981 - DE95008299

Product code DSI

K083517Class IIIntellivue Patient Monitor, Models Mp2, Mp5, Mp20, Mp30, Mp40, Mp50, Mo60, Mp7-, Mp80, and Mp90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2009-01-16

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)