Device Recall Heartstart

Serial Numbers:  US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377

Cardiovascular Devices

3

No

No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 || Product Usage: || 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

US00588464, US00588657, US00589878, US00591080, US00593861

Cardiovascular Devices

3

No

Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) || Product Automated external defibrillators (non-wearable) || Product Usage: || 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.

Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020

Cardiovascular Devices

3

No

Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Canada, AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, 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, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and YEMEN.

HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: 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.

US00100253, US00547494, US00565643, US00567331, US00100950, US00558361, US00565651, US00567332, US00204282, US00560173, US00565652, US00567333, US00210992, US00560174,US00565653, US00567334, US00210993, US00560175, US00565655, US00567335, US00210994, US00560176, US00565656, US00567336, US00210995, US00560177, US00565657, US00567337, US00210996, US00560178, US00565658, US00567338, US00210997, US00561068, US00565660, US00567339, US00210998, US00561724, US00565661, US00567340,  US00210999, US00563602, US00565662, US00567341, US00211000, US00563603, US00565663, US00567720, US00211001, US00563606, US00565664, US00567721, US00212264, US00563607, US00565665, US00567722, US00212265, US00565069, US00565666, US00567723,  US00212266, US00565414, US00566434, US00567724, US00212267, US00565415, US00566564, US00568419, US00212268, US00565416, US00567302, US00568656, US00322574, US00565417, US00567303, US00568703, US00322575, US00565418, US00567304, US00568704 US00322876, US00565419, US00567305, US00568705, US00322877, US00565420, US00567306, US00568706, US00323134, US00565421, US00567307, US00568748, US00323135, US00565422, US00567308, US00568749, US00323137, US00565423, US00567309, US00568750,  US00323138, US00565424, US00567310, US00568751, US00541205, US00565425, US00567311, US00568752, US00541250, US00565427, US00567312, US00568753, US00541254, US00565428, US00567313, US00568754, US00541364, US00565429, US00567314, US00568755,  US00541370, US00565430, US00567315, US00568756, US00541397, US00565446, US00567316, US00568757, US00541402, US00565447, US00567317, US00568758, US00541403, US00565448, US00567318, US00568759, US00541405, US00565449, US00567319, US00568760,  US00543683, US00565450, US00567320, US00568761, US00543684, US00565451, US00567321, US00568762, US00543860, US00565452, US00567322, US00568763, US00544078, US00565453, US00567323, US00568764, US00544082, US00565454, US00567324, US00568765,  US00544089, US00565455, US00567325, US00568766, US00544095, US00565456, US00567326, US00568767, US00547383, US00565457, US00567327, US00568768, US00547456, US00565458, US00567328, US00568769, US00547457, US00565459, US00567329, US00568770, US00547458, US00565642, US00567330, US00568771

Cardiovascular Devices

3

No

Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain.

M3536A HeartStart MRx with Wireless Link Upgrade (861289) || 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.

Cardiovascular Devices

3

No

Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.

Philips HeartStart FR2+ Defibrillator || Automated External Defibrillator (AED) || Catalog Numbers: M3860A/M3861A/M3840A/M3841A