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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 Recall
Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System
see related information
Date Posted July 11, 2011
Recall Status1 Terminated on January 08, 2014
Recall Number Z-2786-2011
Recall Event ID 58885
Premarket Notification
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, Pennsylvania 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = SIEMENS MEDICAL SOLUTIONS USA, INC.
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