# FDA recall Z-3216-2024

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2024-08-15.

## Product

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

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,

## Key facts

- **Recall number:** Z-3216-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-15
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issaquah, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3216-2024

## Citation

> AI Analytics. FDA recall Z-3216-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-3216-2024. Source: US FDA. Licensed CC0.

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