The Recall Desk
HighFDA (Devices)·Z-1601-2024·Announced 2024-05-01

Diagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export

ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.

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: This FDA Class II medical device recall involves a software display defect that could lead to patient misdiagnosis. No illnesses or injuries have been reported, and the harm is potential rather than realized, placing it in the 'High' severity category per the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ACUSON Maple Diagnostic Ultrasound Systems (models REF 11711750 and 11711779, running software version VA10A) are subject to this recall. The systems are affected when the Cardiac DICOM Structured Report (SR) feature is configured to display either minimum or maximum measured values.

When multiple cardiac region measurements are made and results are exported into the SR feature, the system displays the LAST measured value instead of the minimum or maximum value as configured. This display error could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

Approximately 67 systems have been distributed worldwide, including throughout the United States and to numerous international countries. Healthcare facilities with affected serial numbers should identify impacted systems.

Affected facilities should contact Siemens Medical Solutions USA, Inc. for remediation steps. Do not rely on the minimum or maximum values displayed by the Cardiac DICOM SR feature on affected systems until the issue is resolved through vendor-provided updates or validation.

The recalled product

Product
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Cardiac Diagnostic Ultrasound
Hazard
  • diagnostic-error
  • display-defect

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 (1)

  • REF/UDI-DI: 11711750/04056869995809

Distribution

Distributed nationwide across the United States.

Related recalls

Same category