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U.S. Department of Health and Human Services

Class 2 Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging

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 Class 2 Recall
ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging
see related information
Date Posted November 26, 2010
Recall Status1 Terminated on January 06, 2011
Recall Number Z-0469-2011
Recall Event ID 52040
Premarket Notification
510(K) Numbers
K001796  K031815 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Healthcare Call Center
800-722-9277
Manufacturer Reason
for Recall
Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil. Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.
Quantity in Commerce 389 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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