Device Recall Philips

This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010

Cardiovascular Devices

3

No

Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LEBANON LIBYAN ARAB JAMAHIRI LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA SAUDI ARABIA SERBIA&MONTE; NEGRO SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA VIET NAM YEMEN

HeartStart MRx Defibrillator/Monitor || Models: M3535A / M3536A / M3536J / M3536MC || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Serial Number range ARYE-0014 to ASBC-0013

Anesthesiology Devices

2

No

Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds

Serial Number range ARZC-0202 to ASBE-0086

Anesthesiology Devices

2

No

Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds

Serial Number range 4614H27003 to 4614H28158

Anesthesiology Devices

2

No

Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds

Serial Number range 4614H27160 to 4614H28184

Anesthesiology Devices

2

No

Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Philips M1026BT Gas Modules with manifolds