Philips

Serial numbers are:  4810A03287, 4810A03260, 4810A03261, 4810A03262, 4810A04902, 4810A04906, 4810A04907, 4810A04908, 4810A04909, 4810A04910, 4810A04911, 4810A04912, 4810A05422, 4810A05423, 4810A11902, 4810A03367, 4810A03368, 4810A03369, 4810A03370, 4810A03372, 4810A03231, 4810A03240, 4810A03241, 4810A03242, 4810A03254, 4810A03255, 4810A03256, 4810A03257, 4810A03243, 4810A03244, 4810A03245, 4810A02772, 4810A04096, 4810A04097, 4810A04094, 4810A04095, 4810A04084, 4810A04085, 4810A03710, 4810A03711, 4810A03407, 4810A03408, 4810A03409, 4810A03410, 4810A04494, 4810A03934, 4810A03935, 4810A04768, 4810A04783, 4810A04809, 4810A04810, 4810A03631, 4810A04805, 4810A04598, 4810A11904, 4810A04053, 4810A11873, 4810A05158, 4810A05167, 4810A03078, 4810A03762, 4810A11903, 4810A05378, 4810A04798, 4810A04799, 4810A04800, 4810A04764, 4810A04765, 4810A04801, 4810A04802, 4810A04803, 4810A04804, 4810A04784, 4810A04785, 4810A04786, 4820A10136, 4820A10138, 4820A10139, 4820A10124, 4820A10125, 4820A11906, 4820A11905, 4810A03623, 4810A04796, 4810A04763, 4810A04777, 4810A04778, 4810A04779, 4810A04780, 4810A04781, 4810A09398, 4810A11851, 4810A03643, 4810A04664, 4810A04650, 4810A04651, 4810A04652, 4810A09748, 4810A09749, 4810A04565, 4810A04567, 4810A04568, 4810A05277, 4810A05278, 4810A05280, 4810A05281, 4810A04437, 4810A04438, 4810A05288, 4810A05289, 4810A05290, 4810A05291, 4810A05292, 4810A05293, 4810A05282, 4810A05283, 4810A05284, 4810A05285, 4810A05286, 4810A05287, 4810A04573, 4810A04574, 4810A04663, 4810A02713, 4810A02714, 4810A02715, 4810A02716, 4810A02762, 4810A02770, 4810A05397, 4810A05398, 4810A05399, 4810A05400, 4810A11881, 4810A05424, 4810A09648, 4810A09649, 4810A09650, 4810A09651, 4810A03699, 4810A03700, 4810A03702, 4810A03703, 4810A02941, 4810A02942, 4810A02943, 4810A02944, 4810A02945, 4810A02946, 4810A02947, 4810A02948, 4810A09687, 4810A11858, 4810A11877, 4810A02976, 4810A02962, 4810A02963, 4810A02964, 4810A02965, 4810A02966, 4810A02922, 4810A05425, 4810A05413, 4810A05417, 4810A04557, 4810A04555, 4810A04556, 4810A04504, 4810A04505, 4810A04506, 4810A04507, 4810A04508, 4810A04509, 4810A04510, 4810A04511, 4825A06062, 4825A06065, 4825A06063, 4825A06064, 4810A09047, 4810A09048, 4810A09049, 4810A09050, 4810A09051, 4810A09052, 4810A09053, 4810A09054, 4810A09055, 4810A09056, 4810A09084, 4810A09085, 4810A09086, 4810A09087, 4810A09302, 4815A05570, 4815A05571, 4815A05574, 4815A05573, 4810A05247, 4810A09756, 4810A11893, 4810A11894, 4810A10015, 4810A10016, 4810A10018, 4810A10019, 4810A10020, 4810A10021, 4810A02915, 4810A02874, 4825A06101, 4825A06102, 4825A06116, 4825A06117, 4810A09436, 4810A10078, 4810A10079, 4810A10083, 4810A09634, 4810A09635, 4810A09654, 4810A09655, 4810A09656, 4810A09657, 4810A09640, 4810A09645, 4810A09658, 4810A09641, 4810A09642, 4810A09659, 4810A09660, 4810A09661, 4810A09662, 4810A09463, 4810A09425, 4810A09462, 4810A09464, 4810A09892, 4810A09894, 4810A09876, 4810A09877, 4810A09878, 4810A09879, 4810A09880, 4810A09881, 4810A09895, 4810A09893, 4810A09882, 4810A09883, 4810A09884, 4810A05147, 4810A04228, 4810A04292, 4810A04293, 4810A04294, 4815A05914, 4815A05915, 4815A05882, 4815A05883, 4815A05884, 4815A05901, 4815A05902, 4815A05903, 4815A05904, 4815A05905, 4815A05906, 4810A02786, 4810A02787, 4810A02788, 4825A06053, 4825A06049, 4825A06050, 4825A06051, 4825A06052, 4825A06044, 4825A06045, 4825A06046, 4825A06047, 4825A06048, 4825A06092, 4825A06038, 4825A06039, 4825A06040, 4825A06041, 4825A06042, 4825A06043, 4825A06056, 4810A04970, 4810A04971, 4810A04974, 4810A04975, 4810A04976, 4810A04977, 4810A04978, 4810A04979, 4810A05030, 4810A05031, 4810A03323, 4810A03324, 4810A03325, 4810A09359, 4810A09360, 4810A05083, 4810A04544, 4810A04545, 4810A04546, 4810A04547, 4810A04548, 4810A04550, 4810A04551, 4810A04552, 4810A04553, 4810A09215, 4810A09199, 4810A09200, 4810A09201, 4810A09202, 4810A09203, 4810A09212, 4810A04558, 4810A04559, 4810A04560, 4810A04561, 4810A04562, 4810A04563, 4810A04564, 4810A04048, 4810A04049, 4810A04050, 4810A04051, 4810A11857, 4810A10087, 4810A10088, 4810A10089, 4810A10090, 4810A10091, 4810A10092, 4810A10093, 4810A10094, 4815A05948, 4815A05949, 4815A05950, 4815A05951, 4815A05895, 4815A05896, 4815A05897, 4815A05898, 4810A04812, 4810A04813, 4810A03652, 4810A03653, 4810A03839, 4810A11896, 4810A11897, 4810A03575, 4810A03576, 4810A03577, 4810A03578, 4810A03581, 4810A03582, 4810A03583, 4810A03584, 4810A05406, 4810A05407, 4810A09574, 4810A09575, 4810A09576, 4810A09577, 4810A09578, 4810A09579, 4810A04662, 4810A04673, 4810A04674, 4810A03206, 4810A04303, 4810A04304, 4810A04305, 4810A04306, 4810A04386, 4810A05459, 4810A05460, 4810A05461, 4810A05504, 4815A05813, 4815A05814, 4815A05818, 4810A04124, 4810A04125, 4810A04126, 4810A04127, 4810A04128, 4810A04129, 4810A04352, 4810A04353, 4810A04354, 4810A04355, 4815A05604, 4815A05617, 4815A05618, 4815A05619, 4815A05634, 4810A04980, 4810A04998, 4810A04999, 4810A05000, 4810A05001, 4810A05002, 4810A03229, 4810A03205, 4810A03249, 4810A03204, 4810A03230, 4810A03250, 4810A05024, 4810A04981, 4810A04982, 4810A04983, 4810A04984, 4810A05025, 4810A05026, 4810A05027, 4810A05028, 4810A05009, and 4810A05012.

Cardiovascular Devices

2

No

Nationwide Distribution

The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". || The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. || Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

Serial Numbers within the range of US00442485 through US00469873.   The following additional units are also affected because their energy select switches were replaced within the relevant time period: Serial Numbers:  US00100353 US00110688 US00121145 US00338153 US00100741 US00110914 US00121658 US00439208 US00100843 US00111399 US00123159 US00439504 US00101080 US00112143 US00124026 US00439652 US00101500 US00112685 US00125012 US00439661 US00102492 US00114680 US00125049 US00439688 US00102580 US00114900 US00125344 US00439930 US00102583 US00116677 US00126424 US00441252 US00102601 US00116965 US00127322 US00441758 US00102643 US00117003 US00127620 US00441855 US00103225 US00118060 US00213344 US00441862 US00103916 US00118260 US00213559 US00104178 US00118602 US00230434 US00105134 US00118915 US00230588 US00106329 US00118985 US00231849 US00106922 US00119444 US00232228 US00108281 US00119624 US00232394 US00108296 US00120241 US00233505 US00109777 US00120466 US00234442 US00110403 US00120589 and US00234615.

Cardiovascular Devices

3

No

Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS and YEMEN.

HeartStart XL Model M4735A Defibrillator, Automatic, External || Defibrillator-Monitor. || The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Units with serial numbers in the range of DE53001002 through DE53107383.

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution

Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

Site Numbers:  506250, 506251, 506276, 519152, 520209, 521153, 530573, 530607, 532426, 532779, 533491, 533574, 534207, 534419, 534644, 534647, 534675, 534803, 534945, 535378, 535437, 535785, 536051, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536933, 536941, 536973, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538814, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539377, 539378, 539379, 539411, 539419, 539488, 539501, 539519, 539527, 539529, 539530, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884, 542061, 542121, 542122, 542205, 542308, 542401, 542521, 542537, 542589, 542593, 542716, 542829, 542849, 543136, 543144, 543224, 543241, 543249, 543275, 543297, 543331, 543369, 543415, 543426, 543619, 543620, 543660, 543723, 543754, 543755, 543771, 543776, 543803, 543841, 544075, 544113, 544172, 544228, 544236, 544297, 544341, 544417, 544480, 544481, 544568, 544648, 544654, 544695, 544937, 544999, 545000, 545038, 545120, 545163, 545166, 545213, 545231, 545234, 545244, 545391, 545452, 545710, 545746, 545780, 545783, 545824, 545844, 545923, 545948, 545951, 546029, 546155, 546490, 546524, 546551, 546583, 546602, 547054, 547189, 547243, 547297, 547304, 547371, 547598, 547599, 547655, 547657, 547744, 547758, 547759, 547798, 547936, 547937, 548021, 548276, 548290, 548302, 548382, 548559, 548784, 549008, 549080, 549269, 549270, 549381, 549416, 549509, 549557, 549616, 549663, 550072, 550079, 550197, 550313, 550591, 550804, 550936, 550960, 551005, 551416, 551573, 551616, 551645, 551721, 551759, 551941, 551954, 551980, 552204, 552205, 552211, 552324, 552363, 552364, 552407, 552502, 552579, 552594, 552626, 552640, 552917, 552918, 552965, 552966, 553013, 553172, 553207, 553224, 553230, 553275, 553349, 553387, 553441, 553448, 553455, 553563, 553850, 553893, 553900, 553926, 554061, 554483, 554581, 554641, 554721, 554722, 554769, 555052, 555269, 555458, 555524, 555574, 555626, 555964, 555993, 556124, 556621, 556622, 556726, 556785, 556984, 557177, 557259, 557272, 558437, 558596, 558734, 558775, 41443799, 41444441, 41658234, 41862667, 42039161, and 537967 / 49371595.

Radiology Devices

2

No

Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. Devices are not distributed to any foreign consignees.

Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.

Site Numbers:  50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.

Radiology Devices

2

No

Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX

Philips EasyVision MM workstation with software R10.2 and R11.1 || The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.