Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging

Site Numbers:  10009, 10353, 10409, 10432, 13056, 13057, 13894, 17648, 25958, 25986, 26201, 26219, 26269, 35394, 37986, 38111, 38134, 38143, 38303, 38304, 38420, 38438, 38966, 41345, 41391, 45016, 50336, 59435, 59637, 59712, 62450, 62658, 62832, 63046, 76320, 76321, 76359, 76475, 76847, 82546, 82619, 83080, 83301, 83303, 83306, 83325, 83394, 83396, 83804, 83876, 83940, 83946, 83995, 84433, 84477, 84478, 84700, 84820, 84860, 84887, 84899, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85442, 85500, 85684, 85685, 85686, 85688, 86019, 86056, 86080, 86085, 86121, 86147, 86184, 86236, 86280, 86281, 86292, 86293, 86313, 86317, 86334, 86335, 86381, 86404, 86406, 86407, 86410, 86557, 86560, 86570, 86595, 86596, 86968, 87011, 87018, 87033, 87038, 87053, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87526, 87527, 87605, 87607, 100214, 100459, 100460, 100462, 100469, 100478, 100745, 100785, 100786, 100826, 100832, 100916, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101420, 101429, 101431, 101477, 101481, 101551, 101561, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101976, 102003, 102004, 102018, 102095, 102110, 102137, 102492, 102547, 102548, 102561, 102569, 102571, 102671, 102709, 102718, 102724, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103068, 103099, 103126, 103135, 103136, 103142, 103143, 103149, 103166, 103171, 103207, 103215, 103243, 103247, 103291, 103324, 103333, 103347, 103351, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103631, 103665, 103688, 103703, 103770, 103782, 103789, 103811, 103847, 103904, 103946, 104022, 104032, 104054, 104069, 104070, 104082, 104095, 104102, 104138, 104163, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104532, 104639, 104765, 104800, 104808, 104871, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104942, 105148, 105252, 105271, 105290, 105303, 105314, 105315, 105317, 105348, 105368, 105471, 105486, 105488, 105624, 105657, 105687, 105695, 105741, 105925, 105926, 105929, 105938, 225313, 250050, 250122, 250156, 250293, 250890, 500009, 500034, 504243, 504249, 504342, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504662, 504670, 504738, 504866, 505021, 505049, 505050, 505275, 505337, 505357, 505490, 505514, 505568, 505678, 505777, 505785, 505914, 505940, 505941, 505943, 506034, 506044, 506188, 506190, 506203, 506219, 506296, 506324, 506389, 506570, 506691, 506777, 519124, 519127, 519129, 519147, 519216, 519522, 519525, 519545, 520002, 520113, 520354, 520709, 521429, 530363, 530651, 531767, 533741, 536318, 536649, 542669, 544006, 544503, 545940, 546669, 547235, 550391, 556698, 557719, 557722, 557723, 557724, 557791, 557793, 557801, 557805, 557806, 557807, 557813, 557814, 557843, 557844, 557904, 558118, 558147, 558177, 558200, 558369, 558371, 558374, 558381, 558382, 41923351, and 43668550.

Radiology Devices

2

No

Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VA, WA, WI, WV, WY, and Washington DC. There were no foreign consignees.

The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". || The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of the affected system is labeled as 4522-131-6656x.