ACUSON NX2 Elite Diagnostic Ultrasound System recall
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A…
Why was ACUSON NX2 Elite Diagnostic Ultrasound System recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C
- Product
- ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A…
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 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.
- Recall date
- August 28, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)