Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Power Defect
Siemens is recalling ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (excessive acoustic output) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,869 ACUSON NX2 Diagnostic Ultrasound Systems, Model # 11284381. The affected systems contain software versions VA10A, VA10B, VA11A, or VA11B. These devices are intended for cardiac, fetal, abdominal, pediatric, and other diagnostic imaging applications.
The recall was initiated due to internal testing that identified a possibility for transducers to exceed the acoustic output power (AOP) values defined in the specifications. The issue occurs because transit voltage values based on PW Doppler are calculated normally but are not loaded correctly into the hardware.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software defect.
The recalled product
- Product
- ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardi
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 1,869
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 # 11284381 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · excessive acoustic output
See all →- SevereHitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
FDA (Devices) · 2021-03-31
- HighSiemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect
FDA (Devices) · 2019-08-28