The Recall Desk
ModerateFDA (Devices)·Z-2351-2019·Announced 2019-08-28

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.

What this means for you

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.
Category
Medical Device — Diagnostic Ultrasound
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

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.

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