FDAFebruary 23, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
What to do
FDA enforcement status: Ongoing
Brands named
siemens medical solutionssiemenssiemens medical
UPCs
0405686915205904056869957357
Recall history
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