Z-2351-2019Class II

ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions...

Name: Z-2351-2019 ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2019-01-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-01-28 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B... on 2019-01-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2351-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-28
Posted: 2019-08-22
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
Root cause tag: software
FDA 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 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].
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.
Product codes and lots: All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2351-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2350-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2351-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2352-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2353-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)