Z-3216-2024Class II

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

Name: Z-3216-2024 ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Creator: Siemens Medical Solutions USA, Inc.
Published: 2024-08-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2024-08-15 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software on 2024-08-15. FDA classified it as Class II and gives the reason as "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...". 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-3216-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-15
Posted: 2024-09-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
Root cause tag: software
FDA root cause: Software design
Action: On 8/15/2024, correction notices were distributed to customers who were asked to do the following: To avoid potential misdiagnosis by an under-represented volume flow measurement value, use the factory default display configuration of l/min (liters per minute). Review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in milliliters. Firm's Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available in the summer of 2024. Ensure that all users of ACUSON Juniper and ACUSON Maple systems within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. If you have further questions, please contact the firm's Ultrasound Service Customer Care Center at 1-800-888-7436.
Quantity in commerce: 1990
Distribution: 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
Product codes and lots: 11503314, UDI-DI: 04056869251264: 1.0/Software VA10G and prior, 2.0/Software VA20K and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3216-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3215-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3216-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3217-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24

Product code IYN

K210743Class IIACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2021-04-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)