Events

Recall of Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transducer

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
    52928
  • Event Risk Class
    Class 2
  • Event Number
    Z-1961-2011
  • Event Initiated Date
    2009-03-21
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84291
  • 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, imaging, pulsed echo, ultrasonic - Product Code ITX
  • Reason
    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.
  • 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.

Device

Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transd...
  • Model / Serial
    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, 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA