Model M3535A: US00100100 to US00552845; Model M3536A: US00100902 to US00552848; Model M3536M: US00500002 to US00501201; Model M3536MC: US00500001 to US00500087; Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679; Model M3536M5: US00500001 to US00552801 Note: Not every serial number within the listed ranges are affected by this Medical Device Correction. Philips HeartStart MRx Monitors/Defibrillators (1) within the identified serial number range AND (2) meeting one or both of the conditions below are affected by the issue. Condition #1: Device has EtCO2 Option. Devices with the EtCO2 option are affected. To determine if an MRx has the EtCO2 option, press the Menu Select button to open the Main Menu. Use the Navigation and Menu Select buttons to select Other, followed by Print Device Info. Devices with EtCO2 option have etCO2 printed under Options on the printed strip. Condition #2: Device has Old Cap Plate. Devices with a paddle tray or the new cap plate are not affected. New Cap Plate (NOT affected) positions the handle in the middle of the cap plate and covers the entire top of the MRx.
Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NETHERLAND ANTILLES, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, AND YEMEN.
Description du dispositif
Philips HeartStart MRx Monitor/Defibrillator || Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 || 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
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Description du dispositif
Brilliance iCT || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.