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.
What this means for you
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.
- Hazard
- software-error
- incorrect-measurement
- misdiagnosis-risk
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
Distributed in 42 states:
- AL
- AR
- AZ
- CA
- CT
- FL
- GA
- GU
- HI
- IA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- NC
- ND
- NE
- NH
- NJ
- NM
- NY
- OH
- OK
- OR
- PR
- RI
- SC
- SD
- TN
- TX
- VA
- WA
- WI
- WY
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