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U.S. Department of Health and Human Services

Medical Device Recalls
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  Medical Device Recalls see related information
Date Initiated by Firm August 31, 2010
Create Date September 29, 2010
Recall Status1 Terminated 3
Recall Number Z-2626-2010
Recall Event ID 56646
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
Code Information Serial Number range: DE83604981 - DE95008299
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Same
978-687-1501
Manufacturer 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.
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
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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