Device Recall SONOLINE Antares

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.

Radiology Devices

2

No

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.

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