Recall Z-0297-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
| Date | Jan 9, 2008 (initiated Jul 10, 2007) |
| Status | Terminated |
| Reason | Image errors: 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI, Jan 5, 2007 |