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Open, Classified

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.

FDA Recall Z-2351-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2019-01-28
Product Quantity70 systems

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

Firm 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: [email protected].

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2018-02-02K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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