ClearanceBrief
Recall Z-2351-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Siemens Medical Solutions USA, Inc.

ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 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,

DateJan 28, 2019
StatusOpen, Classified
ReasonThe 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 causeSoftware design
ActionA "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
Quantity70 systems
DistributionWorldwide 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 recordOpen on fda.gov

510(k) clearances named in this recall

K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc., Aug 15, 2017
K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc. Ultrasound Group, Feb 2, 2018