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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System see related information
Date Initiated by Firm March 31, 2011
Date Posted July 11, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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