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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON NX2 Elite Diagnostic Ultrasound System

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  Class 2 Device Recall ACUSON NX2 Elite Diagnostic Ultrasound System see related information
Date Initiated by Firm January 28, 2019
Create Date August 22, 2019
Recall Status1 Open3, Classified
Recall Number Z-2351-2019
Recall Event ID 83398
510(K)Number K172374  K173981  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Code Information All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 continuous acquisition. You must press the UPDATE key prior to acquiring a real-time (live), pulsed wave Doppler spectrum. For additional information on simultaneous format, refer to Chapter A4 in your Features and Applications Reference manual. 3. A software update which will address this issue is currently being developed. When this software becomes available, a Siemens Healthineers customer service representative will contact you to schedule your system update. If you have any further questions, please contact your Customer Care Center. 4. Please share this information with all personnel within your organization who need to be aware of this issue. If you have any questions, please contact Vice President, Quality, Regulatory and EHS at (650) 694-5398 or EMAIL: mazi.kiani@siemens-healthineers.com.
Quantity in Commerce 70 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, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Republic of Korea, Romania, Ruanda, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, U.A.E., Uganda, Ukraine, United Kingdom, Uruguay, Uzbekistan and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Siemens Medical Solutions USA, Inc.
510(K)s with Product Code = IYN and Original Applicant = Siemens Medical Solutions USA, Inc. Ultrasound Group
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