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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc.: ACUSON Ultrasound Systems Recalled for Potential Misdiagnosis Risk

Agency Publication Date: September 24, 2024
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Summary

Siemens Medical Solutions USA, Inc. has recalled approximately 9,333 ACUSON Juniper, Redwood, and Maple ultrasound systems due to a software defect that causes incorrect measurement conversions. If a user changes the factory default settings to measure flow in milliliters, the system performs a mathematical error that makes the resulting values 10 times smaller than they actually are. This error could lead to an incorrect diagnosis or negatively impact how a patient's medical condition is managed. The affected units were distributed globally and include various software versions for each model.

Risk

The software uses a multiplier of 100 instead of 1,000 when converting liters to milliliters, causing the device to display flow rates that are significantly lower than the true measurement. This inaccurate data can mislead healthcare providers, potentially resulting in the wrong treatment plan or a missed diagnosis for the patient.

What You Should Do

  1. Identify if your facility uses ACUSON Juniper (REF 11335791, 11653093), ACUSON Redwood (REF 11503314), or ACUSON Maple (REF 11711750, 11711779) Diagnostic Ultrasound Systems.
  2. Check the software version on your device to see if it matches the affected versions: ACUSON Juniper (versions 1.0/VA10G, 1.5/VB10H, 2.0/VB11C, 2.5/VB30D and prior), ACUSON Redwood (versions 1.0/VA10G and 2.0/VA20K and prior), or ACUSON Maple (Software VA10A).
  3. Avoid changing the system measurements from the factory default to 'Milliliters per second' (ml/sec) or 'Milliliters per minute' (ml/min) until a software fix is applied.
  4. Verify any recent measurements that were performed using milliliter-based flow settings to ensure diagnostic accuracy was not compromised.
  5. Contact Siemens Medical Solutions USA, Inc. at their Issaquah, Washington headquarters or through your local service representative for technical guidance and information on the software correction.
  6. Contact your healthcare provider if you have concerns about a diagnosis that may have been based on ultrasound measurements from these specific systems.
  7. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software correction and diagnostic verification.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ACUSON Juniper Diagnostic Ultrasound System
Model / REF:
REF: 11335791
UDI-DI: 04056869152059
Lot Numbers:
1.0/VA10G and prior
1.5/VB10H and prior
2.0/VB11C and prior
2.5/VB30D and prior
Product: ACUSON Juniper Select Diagnostic Ultrasound System
Model / REF:
REF: 11653093
UDI-DI: 04056869957357
Lot Numbers:
2.0/VB11C and prior
2.5/VB30D and prior
Product: ACUSON Redwood Diagnostic Ultrasound System
Model / REF:
REF: 11503314
UDI-DI: 04056869251264
Lot Numbers:
1.0/Software VA10G and prior
2.0/Software VA20K and prior
Product: ACUSON Maple Diagnostic Ultrasound System
Model / REF:
REF: 11711750
UDI-DI: 04056869995809
Lot Numbers:
Software VA10A
Product: ACUSON Maple Select Diagnostic Ultrasound System
Model / REF:
REF: 11711779
UDI-DI: 04056869995830
Lot Numbers:
Software VA10A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95254
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc.
Sold By: Siemens Medical Solutions USA, Inc.; Medical device distributors
Manufactured In: United States
Units Affected: 3 products (7022; 1990; 321)
Distributed To: Mississippi, Washington, Texas, New Jersey, Georgia, New York, Alabama, Minnesota, Nebraska, Indiana, Connecticut, California, Illinois, Tennessee, Wisconsin, North Dakota, New Mexico, Arkansas, North Carolina, Puerto Rico, Rhode Island, Wyoming, Maryland, Florida, Hawaii, Arizona, South Carolina, Missouri, Oklahoma, Virginia, Maine, Kansas, Michigan, Louisiana, Iowa, Ohio, South Dakota, New Hampshire, Kentucky, Oregon, Massachusetts, Guam

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.