Home / Recalls / Siemens Medical Solutions USA, Inc. / Z-3216-2024

Z-3216-2024 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc. — Issaquah, WA

FDA device recall Z-3216-2024 was initiated by Siemens Medical Solutions USA, Inc. on Aug 15, 2024 and is designated Class II. Reason for recall: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect… The recall status is ongoing. Affected quantity: 1990.

Recall Details

Product Type: Devices
Report Date: Oct 2, 2024
Initiation Date: Aug 15, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1990

Product Description

ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

Reason for Recall

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

Distribution Pattern

US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU. OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Congo, the Democratic Republic of the, Costa Rica, C¿te dIvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guinea, French Polynesia, Georgia, Germany, Greece, Guatemala, Guernsey, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein LI B, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Malta, Mexico, Moldova, Rep. of, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Reunion, Romania, Ruanda, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe

Code Information

11503314, UDI-DI: 04056869251264: 1.0/Software VA10G and prior, 2.0/Software VA20K and prior

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3216-2024
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.