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

• Date Initiated by Firm: May 01, 2009
• Date Posted: November 26, 2010
• Recall Status: Terminated on January 06, 2011
• Recall Number: Z-0469-2011
• Recall Event ID: 52040
• 510(K)Number: K031815 K001796
• 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 WA 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: Other
• 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 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.