510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0298-2008

Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and...

Siemens Medical Solutions USA, Inc. / initiated 2007-07-10 / Terminated / root cause: software
FDA source (opens on fda.gov)

Siemens Medical Solutions USA, Inc. began a recall of Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0298-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
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
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall
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.
Root cause tag
software
FDA root cause
Software design
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.
Quantity in commerce
418 units (Z-0297-0298-2008)
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 codes and lots
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.