ACUSON Redwood 1.0 ultrasound displays incorrect cardiac measurement values
The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a software display error that could result in misdiagnosis or poor patient management decisions. No illnesses or injuries have been reported, making this a theoretical risk of harm rather than confirmed harm, which per the rubric places it at Score 3 (High).
Plain-English summary
The ACUSON Redwood 1.0 Diagnostic Ultrasound System (REF 11503314, software versions VA10A to VA10G) is subject to a recall due to a software display error in the Cardiac DICOM Structured Report feature.
When the Cardiac DICOM SR feature is configured to display either minimum or maximum measured cardiac values, and multiple measurements are made and exported, the SR viewer displays the last measured value instead of the configured minimum or maximum value. This could lead to clinicians reviewing incorrect data when making diagnostic or treatment decisions for cardiac patients.
Approximately 628 affected systems have been distributed worldwide, including throughout the United States and over 100 countries. Healthcare providers using these systems should contact Siemens Medical Solutions USA, Inc. for information about available software updates or corrective measures.
The recalled product
- Product
- ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 628
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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