ACUSON Redwood 2.0 Ultrasound Systems Display Incorrect Measurement Results
ACUSON Redwood 2.0 ultrasound systems may display underestimated measurement results when using an 18L6 transducer in Dual format, potentially leading to patient misdiagnosis. 796 units are affected worldwide.
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: Per the severity rubric, this is a risk-of-harm product where injury has not yet been reported. The defect could lead to patient misdiagnosis, but no illnesses or injuries have been reported in the source text.
Plain-English summary
ACUSON Redwood 2.0 ultrasound systems (REF: 11503314, UDI-DI: 04056869251264) with software version prefix VA20 are subject to this recall. A total of 796 units have been distributed worldwide.
The defect occurs when a user-generated preset for an 18L6 transducer created on an ACUSON Redwood 1.0 system is used with a 2.0 system. When this occurs, the 2.0 system displays underestimated measurement results when using the 18L6 transducer in Dual format visualization. These underestimated measurements may lead to patient misdiagnosis or negative influence on patient management decisions.
This is a Class II recall issued by the U.S. Food and Drug Administration for medical devices.
The recalled product
- Product
- ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 796
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 (1)
- UDI-DI: 04056869251264. Systems with software version prefix VA20.
Distribution
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