Events

Recall of Device Recall SONOLINE Antares

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
    45511
  • Event Risk Class
    Class 2
  • Event Number
    Z-0298-2008
  • Event Initiated Date
    2007-07-10
  • Event Date Posted
    2008-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65691
  • 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
    Ultrasound system - Product Code IYN
  • Reason
    Image error: a software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. this is not the case and the actual patient's right and left are reversed from the on-screen indicators.
  • Action
    The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.

Device

Device Recall SONOLINE Antares
  • Model / Serial
    Serial Numbers: 111259, 111264, 111287, 111514, 112013, 112207, 111459, 112730, 113048, 113052, 113053, 113058, 113068, 113075, 113105, 113257, 113259, 113462, 113682, 113759, 113831, 113832, 113841, 113846, 113849, 113850, 113851, 113852, 113854, 113856, 113863, 113945, 113957, 114271, 114274, 114474, 114482, 114583, 114590, 114597, 114644, 114655, 114661, 114687, 114690, 114699, 114703, 114706, 114716, 114749, 114753, 114754, 114760, 114768, 114770, 114771, 114773, 114777, 114782, 114787, 114790, 111259, 111264, 111287, 111514, 111786, 112013, 112207, 111459, 112730, 111552001, 112697001, 10188001, 10566001, 10604001, 111249001, 111552001, 111901001, 111901002, 111994001, 112029001, 112083001, 112178001, 112182001, 112256001, 112306001, 112384001, 112407001, 112697001, 112713001, 112776001, and 113159001.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: Product was distributed to medical facilities Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.
  • Product Description
    Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain View, CA 94039
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

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