Device Recall Philips Healthcare

Software release 2.0.2 and 2.0.2SP1 including mirror icon

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE; NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE

Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon || Stationary Fluoroscopic system

Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952

Cardiovascular Devices

3

No

Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 || 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

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CN21203445, CN21203446, CN21203447, CN21203448, CN21203449, CN21203450, CN21203451, CN21203452, CN21203453, CN21203454, CN21203455, CN21203456, CN21203457, CN21203458, CN21203459, CN21203460, CN21203461, CN21203468, CN21203469, CN21203470, CN21203471, CN21203472, CN21203473, CN21203474, CN21203475, CN21203476, CN21203477, CN21203478, CN21203479, CN21203480, CN21203481, CN21203482, CN21203483, CN21203484, CN21203485, CN21203486, CN21203487, CN21203488, CN21203489, CN21203490, CN21203491, CN21203492, CN21203493, CN21203494, CN21203495, CN21203496, CN21203497, CN21203498, CN21203504, CN21203505, CN21203506, CN21203507, CN21203508, CN21203509, CN21203510, CN21203511, CN21203512, CN21203513, CN21203514, CN21203515, CN21203516, CN21203517, CN21203518, CN21203519, CN21203520, CN21203521, CN21203522, CN21203523, CN21203524, CN21203525, CN21203526, CN21203527, CN21203528, CN21203529, CN21203530, CN21203531, CN21203532, CN21203533, CN21203534, CN21203535, CN21203536, CN21203537, CN21203538, CN21203539, CN21203540, CN21203541, CN21203542, CN21203543, CN21203544, CN21203545, CN21203546, CN21203547, CN21203548, CN21203549, CN21203550, CN21203551, CN21203552, CN21203553, CN21203554, CN21203555, CN21203556, CN21203557, CN21203558, CN21203559, CN21203560, CN21203561, CN21203562, CN21203563, CN21203564, CN21203565, CN21203566, CN21203567, CN21203568, CN21203569, CN21203570, CN21203571, CN21203572, CN21203573, CN21203574, CN21203575, CN21203576, CN21203577, CN21203578, CN21203579, CN21203580, CN21203581, CN21203582, CN21203583, CN21203584, CN21203585, CN21203586, CN21203587, CN21203588, CN21203589, CN21203590, CN21203591, CN21203592, CN21203593, CN21203594, CN21203595, CN21203596, CN21203597, CN21203598, CN21203599, CN21203600, CN21203601, CN21203602, CN21203603, CN21203604, CN21203605, CN21203606, CN21203607, CN21203608, CN21203609, CN21203610, CN21203611, CN21203612, CN21203613, CN21203614, CN21203615, CN21203616, CN21203619, CN21203620, CN21203621, CN21203622, CN21203623, CN21203624, CN21203625, CN21203640, CN21203641, CN21203642, CN21203643, CN21203644, CN21203645, CN21203646, CN21203647, CN21203648, CN21203649, CN21203650, CN21203651, CN21203652, CN21203653, CN21203654, CN21203655, CN21203656, CN21203657, CN21203658, CN21203659, CN21203660, CN21203661, CN21203662, CN21203663, CN21203664, CN21203665, CN21203666, CN21203667, CN21203668, CN21203669, CN21203670, CN21203671, CN21203672, CN21203673, CN21203674, CN21203675, CN21203676, CN21203677, CN21203678, CN21203679, CN21203680, CN21203681, CN21203682, CN21203683, CN21203684, CN21203685, CN21203686, CN21203687, CN21203688, CN21203689, CN21203690, CN21203691, CN21203692, CN21203693, CN21203694, CN21203695, CN21203696, CN21203697, CN21203698, CN21203699, CN21203700, CN21203701, CN21203704, CN21203705, CN21203715, CN21203716, CN21203717, CN21203718, CN21203719, CN21203720, CN21203721, CN21203722, CN21203723, CN21203724, CN21203732, CN21203733, CN21203734, CN21203735, CN21203742, CN21203743, CN21203780, CN21203828, CN21203839, CN21203840, CN21203841, CN21203842, CN21203843, CN21203844, CN21203845, CN21203846, CN21203847, CN21203848, CN21203849, CN21203850, CN21203851, CN21203852, CN21203853, CN21203854, CN21203855, CN21203856, CN21203857, CN21203858, CN21203859, CN21203860, CN21203861, CN21203862, CN21203863, CN21203864, CN21203865, CN21203866, CN21203867, CN21203868, CN21203869, CN21203886, CN21203926, CN21203927, CN21203928, CN21203938, CN21203939, CN21203940, CN21203941, CN21203942, CN21203943, CN21203944, CN21203945, CN21203967, CN21203968, CN21203969, CN21204005, CN21204013, CN21204029, CN21204030, CN21204031, CN21204032, CN21204033, CN21204034, CN21204035, CN21204036, CN21204037, CN21204038, CN21204039, CN21204040, CN21204041, CN21204049, CN21204050, CN21204051, CN21204052, CN21204053, CN21204054, CN21204055, CN21204056, CN21204057, CN21204058, CN21204059, CN21204060, CN21204061,  CN21204062, CN21204063, CN21204064, CN21204065, CN21204066, CN21204067, CN21204068, CN21204069, CN21204070, CN21204071, CN21204072, CN21204073, CN21204074, CN21204075, CN21204076, CN21204077, CN21204078, CN21204079, CN21204080, CN21204081, CN21204082, CN21204083, CN21204084, CN21204085, CN21204086, CN21204087, CN21204088, CN21204089, CN21204090, CN21204091, CN21204092, CN21204093, CN21204094, CN21204095, CN21204096, CN21204097, CN21204098, CN21204099, CN21204100, CN21204101, CN21204119, CN21204131, CN21204134, CN21204144, CN21204145, CN21204201, CN21204202, CN21204224, CN21204226, CN21204283, CN21204284, CN21204285, CN21204286, CN21204287, CN21204292, CN21204309, CN21204310, CN21204311, CN21204312, CN21204317, CN21204322, SP13701043, USPP101007, CN21201390, CN21201500, CN21201501, CN21201502, CN21201503, CN21201505, CN21201506, CN21201507, CN21201508, CN21201509, CN21201510, CN21201511, CN21201512, CN21201513, CN21201514, CN21201515, CN21201516, CN21201517, CN21201518, CN21201519, CN21201520, CN21201521, CN21201522, CN21201523, CN21201524, CN21201525, CN21201526, CN21201527, CN21201528, CN21201529, CN21201530, CN21201531, CN21201532, CN21201533, CN21201534, CN21201535, CN21201536, CN21201537, CN21201538, CN21201539, CN21201540, CN21201541, CN21201542, CN21201543, CN21201544, CN21201545, CN21201546, CN21201568, CN21201569, CN21201570, CN21201580, CN21201581, CN21201582, CN21201583, CN21201584, CN21201585, CN21201586, CN21201587, CN21201588, CN21201589, CN21201590, CN21201591, CN21201592, CN21201593, CN21201594, CN21201595, CN21201596, CN21201597, CN21201598, CN21201599, CN21201600, CN21201601, CN21201602, CN21201619, CN21201620, CN21201621, CN21201763, CN21201764, CN21201765, CN21201766, CN21201767, CN21201790, CN21201791, CN21201792, CN21201793, CN21201794, CN21201800, CN21201801, CN21201802, CN21201803, CN21201815, CN21201816, CN21201817, CN21201818, CN21201819, CN21201820, CN21201821, CN21201822, CN21201823, CN21201824, CN21201829, CN21201830, CN21201831, CN21201832, CN21201833, CN21201834, CN21201835, CN21201836, CN21201837, CN21201838, CN21201839, CN21201840, CN21201841, CN21201842, CN21201843, CN21201872, CN21201873, CN21201874, CN21201875, CN21201876, CN21201877, CN21201878, CN21201879, CN21201880, CN21201881, CN21201882, CN21201883, CN21201884, CN21201885, CN21201902, CN21201903, CN21201904, CN21201905, CN21201906, CN21201907, CN21201908, CN21201909, CN21201910, CN21201911, CN21201912, CN21201913, CN21201914, CN21201915, CN21201916, CN21201986, CN21201987, CN21201992, CN21202039, CN21202093, CN21202162, CN21202163, CN21202203, CN21202204, CN21202205, CN21202236, CN21202237, CN21202323, CN21202339, CN21202340, CN21202341, CN21202342, CN21202343, CN21202344, CN21202346, CN21202374, CN21202375, CN21202395, CN21202396, CN21202397, CN21202398, CN21202399, CN21202400, CN21202401, CN21202402, CN21202403, CN21202404, CN21202405, CN21202406, CN21202407, CN21202408, CN21202409, CN21202410, CN21202411, CN21202412, CN21202413, CN21202414, CN21202481, CN21202482, CN21202483, CN21202484, CN21202485, CN21202486, CN21202487, CN21202488, CN21202489, CN21202490, CN21202491, CN21202492, CN21202493, CN21202494, CN21202495, CN21202496, CN21202497, CN21202498, CN21202499, CN21202500, CN21202501, CN21202502, CN21202503, CN21202504, CN21202505, CN21202506, CN21202507, CN21202508, CN21202509, CN21202510, CN21202511, CN21202512, CN21202513, CN21202514, CN21202670, CN21202671, CN21202672, CN21202673, CN21202674, CN21202675, CN21202681, CN21202682, CN21202684, CN21202685, CN21202686, CN21202687, CN21202841, CN21203031, CN21203046, CN21203047, CN21203048, CN21203049, CN21203050, CN21203051, CN21203052, CN21203053, CN21203074, CN21203075, CN21203076, CN21203077, CN21203078, CN21203079, CN21203080, CN21203081, CN21203082, CN21203083, CN21203084, CN21203085, CN21203086, CN21203087, CN21203088, CN21203089, CN21203090, CN21203091, CN21203092, CN21203093, CN21203094, CN21203095, CN21203154, CN21203155, CN21203156, CN21203157, CN21203189, CN21203190, CN21203191, CN21203192, CN21203193, CN21203194, CN21203214, CN21203215, CN21203216, CN21203217, CN21203218, CN21203219, CN21203220, CN21203221, CN21203232, CN21203233, CN21203234, CN21203235, CN21203236, CN21203237, CN21203238, CN21203239, CN21203240, CN21203241, CN21203242, CN21203243, CN21203244, CN21203245, CN21203246, CN21203247, CN21203248, CN21203249, CN21203250, CN21203251, CN21203252, CN21203290, CN21203291, CN21203292, CN21203293, CN21203294, CN21203295, CN21203296, CN21203297, CN21203323, CN21203324, CN21203337, CN21203338, CN21203339, CN21203363, CN21203383, CN21203384, CN21203385, CN21203386, CN21203387, CN21203393, CN21203394, CN21203395, CN21203396, CN21203397, CN21203404, CN21203405, CN21203406, CN21203407, CN21203408, CN21203409, CN21203410, CN21203411, CN21203412, CN21203413, CN21203414, CN21203417, CN21203462, CN21203463, CN21203464, CN21203465, CN21203466, CN21203467, CN21203636, CN21203709, CN21203710, CN21203711, CN21203712, CN21203741, CN21203750, CN21203751, CN21203752, CN21203753, CN21203829, CN21203830, CN21203831, CN21203832, CN21203833, CN21203834, CN21203835, CN21203836, CN21203837, CN21203838, CN21203871, CN21203872, CN21203873, CN21203874, CN21203875, CN21203876, CN21203877, CN21203878, CN21203879, CN21203880, CN21203881, CN21203882, CN21203883, CN21203884, CN21203885, CN21203900, CN21203901, CN21203902, CN21203903, CN21203904, CN21203905, CN21203906, CN21203907, CN21203908, CN21203909, CN21203910, CN21203911, CN21203912, CN21203913, CN21203914, CN21203915, CN21203916, CN21203917, CN21203918, CN21203919, CN21203920, CN21203921, CN21203922, CN21203923, CN21203954, CN21203955, CN21203956, CN21203957, CN21203958, CN21203962, CN21203963, CN21203964, CN21203971, CN21203972, CN21203973, CN21203974, CN21203975, CN21203976, CN21203977, CN21203978, CN21203979, CN21203980, CN21203981, CN21203982, CN21203983, CN21203984, CN21203995, CN21203996, CN21203997, CN21203998, CN21204006, CN21204012, CN21204014, CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM

Philips Healthcare SureSigns VS2+ || Model 863278 SureSigns VS2+ NBP and SpO2 || Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature || Product Usage: || The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Serial numbers ranging from: US12700465 to US20823366

Cardiovascular Devices

2

No

USA Nationwide Distribution

Radiohead Access Point 1.4 GHz Radiohead Access Point || Firmware versions: C.00.04 & C.00.05 || Part Number: 989803171211 || Product Usage: || IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.

Software versions: F.02, R.02, 9.xx or any earlier versions   Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade

Cardiovascular Devices

3

No

US Nationwide and OUS.

Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement || 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. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.