ACUSON Juniper ultrasound systems display incorrect cardiac measurements
Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.
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 is an FDA Class II recall of a diagnostic ultrasound system where a software error could lead to misdiagnosis through incorrect display of cardiac measurements. While no illnesses or injuries have been reported, the hazard presents a significant risk of patient harm through clinical decision-making based on incorrect measurement data.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ACUSON Juniper Diagnostic Ultrasound Systems (models REF 11335791 and REF 11653093) with software version VA10x and the Cardiac DICOM SR (Structured Report) option. Approximately 5,090 units have been distributed worldwide.
A software error in the DICOM SR viewer causes it to display incorrect cardiac measurement values under specific conditions. When the feature is configured to display either minimum or maximum measured values and multiple cardiac measurements are made and exported to the SR feature, the viewer displays the LAST measured value instead of the configured minimum or maximum. This error could contribute to patient condition misdiagnosis or negatively influence clinical management decisions.
The affected software versions include VB10A through VB10G, VB11A, VB11B, VB30B, and VB30C. Detailed information about affected serial numbers and technical guidance is available from the manufacturer and the FDA.
The recalled product
- Product
- ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- software-error
- incorrect-display
- measurement-error
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: 11335791/04056869152059
Distribution
Distributed nationwide across the United States.
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