Siemens Medical Solutions USA, Inc.: ACUSON Ultrasound Systems Recalled for Cardiac Measurement Software Error

Agency Publication Date: April 19, 2024

Summary

Siemens Medical Solutions USA, Inc. has recalled 5,785 ACUSON diagnostic ultrasound systems, specifically the Juniper, Redwood, and Maple models. The software in these systems contains an error where the viewer displays the last recorded heart measurement instead of the minimum or maximum values as configured by the doctor. This defect affects systems running software version VA10A through various specific updates including VB10 and VB30. If a doctor relies on these incorrect values during a cardiac exam, it could lead to an incorrect diagnosis or improper management of a patient's heart condition.

Risk

The software displays the incorrect measurement value, which can lead healthcare providers to misinterpret a patient's heart health. This poses a medium risk of patient misdiagnosis or the implementation of an inappropriate treatment plan for serious cardiac conditions.

What You Should Do

Identify if your facility uses ACUSON Juniper, ACUSON Redwood 1.0, or ACUSON Maple ultrasound systems.
Check your system software version to see if it falls within the affected range: VA10x (for Juniper), VA10A to VA10G (for Redwood), or VA10A (for Maple).
For ACUSON Juniper systems, verify your unit against serial numbers such as 571063, 556506, or 555717, and check for REF codes 11335791 or 11653093.
For ACUSON Redwood systems, check for REF code 11503314 and serial numbers such as 560821, 560366, or 560250.
For ACUSON Maple systems, check for REF codes 11711750 or 11711779 and serial numbers like 700127, 700125, or 700109.
Contact your healthcare provider or Siemens Medical Solutions directly to discuss the software error and arrange for necessary technical updates or service.
Healthcare providers should manually verify cardiac measurements until a software patch is applied to ensure the correct minimum or maximum values are being recorded and exported.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Other Action

Potential software correction or technical service update.

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

REF: 11653093

Lot Numbers:

Software version VA10x (VB10A to VB10G, VB11A, VB11B, VB30B, VB30C)

Product: ACUSON Redwood 1.0 Diagnostic Ultrasound System

Model / REF:

REF: 11503314

Lot Numbers:

Software version VA10A to VA10G

Product: ACUSON Maple Diagnostic Ultrasound System

Model / REF:

REF: 11711750

REF: 11711779

Lot Numbers:

Software version VA10A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94211

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc.

Sold By: Siemens Medical Solutions USA, Inc.

Manufactured In: United States

Units Affected: 3 products (5090; 628; 67)

Distributed To: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

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 · 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.

Summary

What You Should Do

Identify if your facility uses ACUSON Juniper, ACUSON Redwood 1.0, or ACUSON Maple ultrasound systems.

Check your system software version to see if it falls within the affected range: VA10x (for Juniper), VA10A to VA10G (for Redwood), or VA10A (for Maple).

For ACUSON Juniper systems, verify your unit against serial numbers such as 571063, 556506, or 555717, and check for REF codes 11335791 or 11653093.

For ACUSON Redwood systems, check for REF code 11503314 and serial numbers such as 560821, 560366, or 560250.

For ACUSON Maple systems, check for REF codes 11711750 or 11711779 and serial numbers like 700127, 700125, or 700109.

Contact your healthcare provider or Siemens Medical Solutions directly to discuss the software error and arrange for necessary technical updates or service.

Healthcare providers should manually verify cardiac measurements until a software patch is applied to ensure the correct minimum or maximum values are being recorded and exported.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Affected Products

Product: ACUSON Juniper Diagnostic Ultrasound System

Model / REF:

REF: 11335791

REF: 11653093

Lot Numbers:

Software version VA10x (VB10A to VB10G, VB11A, VB11B, VB30B, VB30C)

Product: ACUSON Redwood 1.0 Diagnostic Ultrasound System

Model / REF:

REF: 11503314

Lot Numbers:

Software version VA10A to VA10G

Product: ACUSON Maple Diagnostic Ultrasound System

Model / REF:

REF: 11711750

REF: 11711779

Lot Numbers:

Software version VA10A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94211

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc.

Sold By: Siemens Medical Solutions USA, Inc.

Manufactured In: United States

Units Affected: 3 products (5090; 628; 67)