—#65691

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

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063803
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-07-10
Posted by FDA: 2008-01-09
Terminated: 2010-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65691. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.