Recall Z-2350-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascul
| Date | Jan 28, 2019 |
| Status | Open, Classified |
| Reason | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware |
| Root cause | Software design |
| Action | A "Customer Safety Advisory Notification" letter was sent to customers on 04/04/2019 via email by Siemens Medical Solutions USA, Inc. The letter was released via update US038/18/S. The letter instructed customers to do the following: 1. To avoid a situation where incorrect acoustic output power values are used during pulsed wave Doppler, always press the UPDATE key prior to acquiring a real-time (live), pulsed wave Doppler spectrum. The ultrasound system updates the acoustic output power values to the correct values after each press of the key. 2. Do not use a simultaneous format for contin |
| Quantity | 1869 systems |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY; and countries of: Albania, Algeria, Angola, Argentina, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161787 | ACUSON NX2 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc., Jul 28, 2016 |
| K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., Aug 15, 2017 |
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Ultrasound Group, Feb 2, 2018 |