Class 2 Device Recall Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System

• Date Initiated by Firm: March 31, 2011
• Date Posted: July 11, 2011
• Recall Status: Terminated on January 08, 2014
• Recall Number: Z-2786-2011
• Recall Event ID: 58885
• 510(K)Number: K993731
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System Nuclear magnetic resonance imaging system
• Code Information: Model numbers 4760265, 7104594, 7104719, 7104735, 7106425 and 7106557. Serial numbers 21604, 21235, 14151, 13314, 14312, 22499, 13438, 22301, 22211, 22311, 14247, 22127, 14436, 14228, 22518, 22165, 22200, 14306, 14426, 13044, 14138, 22438, 14023, 21204, 22344, 14196, 22195, 22276, 22355, 14424, 14369, 14393, 21279, 22491, 14114, 22309, 14344, 14101, 22386, 22523, 14373, 22609, 22305, 22090, 22561, 14394, 14292, 22580, 22524, 22568, 22573, 14144, 22173, 22270, 22511, 14009, 14087, 14175, 22170, 22604, 22115, 14024, 22114, 14383, 22352, 22121, 14097, 14486, 14155, 14234, 21250, 22587, 14204, 22243, 22408, 14060, 13121, 22621, 14323, 22557, 22250, 22029, 21936, 22356, 22079, 22342, 14405, 14338, 22126, 14379, 14015, 22618, 14360, 22463, 22307, 14237, 14206, 14276, 14278, 22418, 22649, 21928, 22643, 14343, 14188, 14376, 14409, 22153, 22642, 22312, 22084, 14387, 22444, 14448, 14314, 22097, 14429, 14072, 21200, 14390, 14348, 14229, 21608, 22543, 21253, 14341, 13108, 22221, 14488, 14066, 22647, 22193, 13523, 14389, 22610, 22321, 14299, 14484, 22316, 14447, 21108, 22298, 14158, 22591, 14231, 14487, 22623, 14385, 22302, 22196, 14201, 14225, 22169, 14368, 22277, 14252, 14319, 22075, 14328, 14265, 13413, 13345, 22237, 21268, 22629, 14444, 14450, 14431, 21926, 22324, 22225, 22241, 22265, 14076, 22483, 14221, 14220, 14346, 22330, 22108, 22650, 22617, 22403, 22134, 22212, 22047, 21174, 22319, 14148, 22608, 22286, 22357, 13135, 21105, 21155, 21201, 22092, 14363, 22145, 14415, 21142, 22322, 14371, 14417, 14438, 22046, 22534, 22441, 22010, 22080, 22435, 14182, 22021, 14198, 21205, 14219, 14270, 14412, 14437, 22536, 22248, 22471, 22503, 22506, 14119, 22242, 14258, 14474, 14452, 22306, 14357, 21611, 14010, 22616, 21262, 22216, 22171, 21119, 22576, 22174, 22407, 14381, 21186, 22162, 22103, 22228, 14386, 14161, 22605, 22346, 22406, 14443, 22565, 22639, 22105, 14380, 22638, 21189, 14044, 14413, 14186, 22215, 14432, 22582, 14423, 22130, 22497, 22024, 22490, 14105, 21906, 14356, 22164, 22093, 22345, 14321, 22636, 14398, 14355, 22607, 13255, 22189, 22190, 22478, 22400, 22579, 22218, 22273, 14041, 14126, 22073, 22451, 14184, 14256, 14288, 22588, 22091, 14232, 14401, 21171, 13110, 22519, 14043, 22271, 22051, 22261, 14453, 22255, 22031, 22520, 22455, 21289, 21238, 22011, 14137, 22551, 14345, 22129, 22207, 14235, 22063, 21249, 22372, 22083, 22402, 13325, 22358, 22572, 22416, 14449, 14180, 21914, 14193, 22113, 22184, 22569, 22433, 22493, 22172, 22606, 14092, 14272, 14427, 14085, 14399, 22622, 22624, 14038, 22266, 22060, 14223, 21202, 22398, 22461, 22244, 21131, 14035, 13475, 22095, 14322, 14433, 22068, 14115, 13415, 14411, 22036, 22050, 14093, 14142, 14313, 14324, 14211, 14261, 22646, 14349, 22429, 22182, 22574, 22625, 22361, 14460, 14146, 21260, 21612, 14160, 22118, 21904, 14215, 14013, 14251, 14397, 22071, 14128, 21107, 21264, 14109, 14430, 21239, 21236, 14177, 14055, 14226, 21232, 22401, 13114, 22272, 22530, 14472, 22596, 21138, 21299, 14189, 14230, 14245, 22464, 21215, 22282, 14036, 14048, 22339, 22602, 22535, 22510, 14334, 22074, 21251, 14340, 22648, 14238, 22615, 14120, 22104, 14434, 22030, 21165, 14362, 22175, 22550, 21248, 14051.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Customer Support; 610-219-6300
• Manufacturer Reason for Recall: Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Siemens initated their recall of the device on March 31, 2001, by sending a Customer Safety Advisory Notice/Letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that detectors will be installed in appropriate locations on the system, which will switch off the system's power electronics in the event of a malfunction in the power supply of the gradient coils, preventing damage to the system and its environment.
• Quantity in Commerce: 440
• Distribution: Nationwide Distribution including AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Puerto Rico.
• 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