Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Philips M3002A IntelliVue X2 Model: 865039 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

FDA Recall Z-2625-2010 · Posted 2010-09-29

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeDSI
Date Initiated2010-08-31
Date Terminated2017-02-15
Product Quantity19,400 units

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082633INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008-10-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑