ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor 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 recall of a diagnostic medical device with potential for serious patient harm through misdiagnosis, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported. No illnesses or deaths are mentioned in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,990 ACUSON Redwood 1.0 and 2.0 diagnostic ultrasound systems due to a software unit conversion error.
If operators change the systems from factory default settings to display measurements in milliliters per second (ml/sec) or milliliters per minute (ml/min), the software will incorrectly convert liters to milliliters using a multiplier of 100 instead of 1,000. This causes displayed values to be approximately 10 times smaller than the actual measurement values.
The incorrect measurements could contribute to misdiagnosis or negatively influence patient management decisions. The systems are used in hospitals and diagnostic imaging facilities across the United States and more than 100 countries worldwide.
Affected healthcare providers should verify that their systems are operating with factory default unit settings and contact Siemens Medical Solutions for guidance if they have questions about their configuration.
The recalled product
- Product
- ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 1,990
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 11503314
- UDI-DI: 04056869251264: 1.0/Software VA10G and prior
- 2.0/Software VA20K and prior
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- HighACUSON Redwood 2.0 Ultrasound Systems Display Incorrect Measurement Results
FDA (Devices) · 2023-09-20
- HighACUSON Redwood 1.0 ultrasound displays incorrect cardiac measurement values
FDA (Devices) · 2024-05-01
- HighUltrasound System Software Calculation Error in Siemens ACUSON Sequoia
FDA (Devices) · 2022-02-09
- ModerateSiemens ACUSON X700 Ultrasound Systems Recalled for Data Error
FDA (Devices) · 2014-04-30
- HighSiemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations
FDA (Devices) · 2021-04-07
- HighSiemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
FDA (Devices) · 2015-08-05