The Recall Desk
HighFDA (Devices)·Z-2353-2019·Announced 2019-08-28

Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect

Siemens is recalling ACUSON NX3 Elite 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 power) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 2,262 ACUSON NX3 Elite Diagnostic Ultrasound Systems (Model # 11235411) containing specific software versions (VA10A through VA10F, VB20A, and VB20B). 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 issue occurs because transit voltage values based on PW Doppler are calculated normally but are not loaded correctly into the hardware.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries. These diagnostic ultrasound systems are intended for various applications, including cardiac, fetal, abdominal, pediatric, and vascular imaging, as well as for clinical diagnosis purposes.

Healthcare providers and consumers should contact Siemens Medical Solutions USA, Inc. for further information regarding the recall and corrective actions. The source text does not specify a specific consumer action other than the initiation of the recall by the manufacturer.

The recalled product

Product
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are int
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
2,262

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 # 11235411 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 →

Same hazard · excessive acoustic output

See all →