Recall Z-1592-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
| Date | Apr 8, 2016 |
| Status | Terminated |
| Reason | While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball. |
| Root cause | Software design |
| Action | Under Siemens update program US013/16/S a Customer Advisory Notification will be mailed to all affected customers by Certified mail with return receipt beginning March 30, 2016. Letters provide customers information on how to avoid the issue until the software patch is installed. |
| Quantity | 87 |
| Distribution | Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |