Recall Z-1766-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202.
| Date | Sep 2, 2008 (initiated Mar 21, 2008) |
| Status | Terminated |
| Reason | Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis. |
| Root cause | Software design |
| Action | The firm initiated a field correction on 03/21/2008. Site visits to correct the problem and install the revised software version 200.0.063A are planned for all consignees. No other notification was made. The firm can be contacted at 650-694-5993. |
| Quantity | 488 active units total |
| Distribution | Product was distributed worldwide to 539 consignees, in the USA to MD, SC, AZ, FL, IL, WI, NJ, NC, CA, OH, VA TX, PA MO, NH, IA, NE, MN, NY, GA, MI, WA, HI, MA, SC, WV, VA, ND, IN, WY, UT, MS, TN, PR, SD, KY, OK, OR, and worldwide to Sweden, Saudi Arabia, Austria, New Zealand, Italy, Switzerland, Me |
| 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 |