Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58885
  • Event Risk Class
    Class 2
  • Event Number
    Z-2786-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100474
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.
  • 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.

Device

Device Recall Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System || Nuclear magnetic resonance imaging system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA