Agency classClass IIOur severity:High FDA (Devices)·Z-2350-2019·Announced 2019-08-28

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.

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: 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…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Diagnostic Ultrasound
Hazard: excessive-acoustic-output
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

Distributed nationwide across the United States.

The notice also names 43 states specifically:

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc.

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