The Recall Desk
HighFDA (Devices)·Z-2352-2019·Announced 2019-08-28

Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide 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. The hazard involves a risk of harm (exceeding acoustic output power) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,384 ACUSON NX3 Diagnostic Ultrasound Systems (Model # 11235612) containing specific software versions (VA10A through VA10F, VB20A, and VB20B). The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall was initiated due to internal testing that identified a possibility for transducers to exceed the acoustic output power (AOP) values defined for the device. The issue stems from transit voltage values based on PW Doppler being calculated normally but not loaded correctly into the hardware.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries. The systems are intended for various diagnostic applications, including cardiac, fetal, abdominal, and vascular imaging. No specific instructions for consumers are provided in the source text, but the devices are prescription-only medical equipment.

The recalled product

Product
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
1,384

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 (9)

  • All product lots of the Acuson NX3
  • model # 11235612 containing the following software version: VA10A
  • VA10B
  • VA10C
  • VA10D
  • VA10E
  • VA10F
  • VB20A
  • and VB20B

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 →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc.

See all →