Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Defect
Siemens is recalling 70 ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which the rubric associates with moderate severity when no hospitalizations or serious injuries are reported. The source text does not mention any reported illnesses or injuries.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 70 ACUSON NX2 Elite Diagnostic Ultrasound Systems (Model # 11284500) containing software versions VA10A, VA10B, VA11A, and VA11B. The recall was initiated after internal testing identified a possibility for transducers to exceed the acoustic output power (AOP) values defined for the device.
The defect involves transit voltage values based on PW Doppler being calculated normally but not loaded correctly into the hardware. The affected systems are intended for cardiac, fetal, abdominal, pediatric, and other diagnostic applications. The units were distributed worldwide, including nationwide in the United States and in numerous international countries.
This is a Class II recall, meaning the use of, or exposure to, the violation is not likely to cause adverse health consequences, but may cause temporary or medically reversible adverse health consequences. Users should contact Siemens Medical Solutions for instructions on how to resolve the issue.
The recalled product
- Product
- ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 70
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 (7)
- All product lots of the Acuson NX2
- model # 11284500 containing the following software: VA10A
- VA10B
- VA10C
- VA11A
- VA11B
- VA11C
Distribution
Part of a larger recall action
This product is one of 4 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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