Z-1961-2011
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia...
Siemens Medical Solutions USA, Inc. / initiated 2009-03-21 / Terminated / root cause: software
Siemens Medical Solutions USA, Inc. began a recall of Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by... on . The reason FDA records is "Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1961-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
- Product code
- ITX Transducer, Ultrasonic, Diagnostic
- Reason for recall
- Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- The firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available. Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.
- Quantity in commerce
- 2591 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- ACUSON Sequoia serial numbers 50026, 50030, 50042, 50043, 50057, 50087, 50108, 50116, 50172, 50202, 50216, 50243, 50252, 50271, 50279, 50295, 50342, 50355, 50368, 50374, 50418, 50425, 50448, 50493, 50497, 50560, 50561, 50604, 50651, 50676, 50680, 50728, 50777, 50788, 50794, 50796, 50806, 50852, 50855, 50893, 50898, 50920, 50938, 50959, 50964, 51020, 51046, 51055, 51087, 51128, 51185, 51213, 51215, 51229, 51243, 51270, 51278, 51290, 51311, 51332, 51350, 51354, 51367, 51389, 51414, 51433, 51446, 51496, 51498, 51514, 51516, 51523, 51524, 51604, 51636, 51639, 51643, 51652, 51740, 51742, 51747, 51757, 51766, 51781, 51792, 51796, 51800, 51811, 51830, 51844, 51846, 51859, 51897, 51899, 51910, 51920, 51926, 51949, 51955, 51971, 51975, 51979, 51980, 51987, 52003, 52006, 52012, 52023, 52040, 52041, 52047, 52059, 52065, 52075, 52087, 52089, 52101, 52111, 52133, 52136, 52143, 52158, 52170, 52191, 52193, 52195, 52200, 52202, 52243, 52252, 52263, 52272, 52274, 52277, 52282, 52285, 52297, 52307, 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68839, 68840, 68842, 68844, 68846, 68847, 68849, 68850, 68852, 68854, 68857, 68858, 68859, 68861, 68862, 68864, 68865, 68873, 68874, 68875, 68876, 68877, 68878, 68879, 68880, 68881, 68882, 68883, 68884, 68886, 68888, 68889, 68890, 68891, 68892, 68893, 68894, 68895, 68896, 68897, 68899, 68900, 68901, 68902, 68904, 68906, 68907, 68908, 68909, 68910, 68912, 68913, 68914, 68917, 68919, 68921, 68923, 68924, 68925, 68926, 68927, 68928, 68929, 68932, 68933, 68934, 68935, 68937, 68938, 68939, 68940, 68941, 68942, 68943, 68948, 68949, 68950, 68951, 68952, 68956, 68957, 68961, 68966, 68967, 68968, 68969, 68970, 68971, 68973, 68977, 68978, 68983, 68984, 68987, 68988, 68989, 68990, 68992, 68996, 68997, 68998, 69000, 69004, 69005, 69006, 69007, 69008, 69009, 69011, 69012, 69013, 69016, 69018, 69019, 69020, 69021, 69023, 69024, 69025, 69026, 69027, 69028, 69029, 69031, 69034, 69036, 69037, 69039, 69040, 69042, 69044, 69045, 69046, 69047, 69048, 69050, 69052, 69053, 69055, 69056, 69057, 69058, 69059, 69060, 69061, 69062, 69063, 69064, 69065, 69066, 69067, 69068, 69069, 69070, 69072, 69073, 69074, 69076, 69077, 69078, 69079, 69080, 69081, 69083, 69085, 69086, 69088, 69089, 69090, 69091, 69092, 69094, 69095, 69096, 69097, 69098, 69101, 69103, 69104, 69105, 69110, 69112, 69113, 69114, 69116, 69117, 69118, 69120, 69121, 69122, 69123, 69124, 69127, 69128, 69129, 69130, 69131, 69132, 69133, 69134, 69135, 69136, 69138, 69143, 69144, 69145, 69146, 69150, 69151, 69152, 69153, 69154, 69155, 69156, 69157, 69158, 69160, 69161, 69162, 69164, 69166, 69167, 69168, 69169, 69170, 69171, 69173, 69174, 69176, 69177, 69179, 69182, 69184, 69185, 69187, 69189, 69190, 69191, 69192, 69193, 69194, 69195, 69196, 69198, 69200, 69201, 69202, 69204, 69205, 69206, 69207, 69208, 69209, 69210, 69212, 69215, 69216, 69217, 69219, 69221, 69222, 69225, 69226, 69228, 69229, 69230, 69231, 69233, 69236, 69242, 69243, 69244, 69245, 69246, 69249, 69253, 69257, 69258, 69264, 69265, 69268, 69269, 69271, 69272, 69274, 69275, 69276, 69277, 69278, 69279, 69280, 69281, 69284, 69285, 69286, 69287, 69288, 69289, 69291, 69292, 69293, 69294, 69295, 69296, 69298, 69299, 69300, 69301, 69302, 69303, 69304, 69305, 69306, 69307, 69308, 69309, 69311, 69312, 69313, 69314, 69315, 69316, 69318, 69319, 69321, 69322, 69323, 69325, 69326, 69327, 69328, 69329, 69330, 69333, 69335, 69337, 69338, 69340, 69341, 69343, 69344, 69346, 69347, 69348, 69349, 69351, 69352, 69353, 69354, 69355, 69356, 69357, 69358, 69359, 69361, 69362, 69364, 69365, 69366, 69367, 69368, 69369, 69371, 69372, 69374, 69375, 69376, 69377, 69378, 69380, 69381, 69382, 69383, 69384, 69385, 69387, 69389, 69390, 69391, 69392, 69393, 69394, 69395, 69397, 69398, 69399, 69400, 69401, 69402, 69403, 69404, 69405, 69406, 69407, 69408, 69409, 69410, 69411, 69416, 69418, 69419, 69423, 69425, 69426, 69428, 69430, 69431, 69432, 69434, 69438, 69439, 69440, 69441, 69445, 69446, 69447, 69449, 69450, 69451, 69452, 69453, 69456, 69459, 69461, 69462, 69464, 69465, 69466, 69467, 69468, 69469, 69470, 69471, 69475, 69482, 69483, 69485, 69486, 69489, 69490, 69491, 69494, 69495, 69502, 69509, 69519, 69520, 69521, 69522, 65677-1, and 65719-1.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.