Reported May 1, 2024 · Ongoing
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System,…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 22010 Se 51st St · Issaquah, WA · 98029-7298
Is this the product you have?
- ACUSON Juniper Diagnostic Ultrasound System
- REF11335791, and ACUSON Juniper Select Diagnostic Ultrasound System
- REF11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
- Lot codes and dates
- REF/UDI-DI
11335791/04056869152059and 11653093/04056869957357
- Serial Numbers
4,646 of 4,646 codes
571063556506555717555502555450555448552655552659550763556982556990556996556998557000557001557002557003555641555631553876553877556233557117557122557123556083556082556080556081556043556044556045556046556047555714555285555281555282555283555286555287555288555290555289555284550462550460550461550915550878573362573314570015573313573132570258570332575056570033556390
- REF/UDI-DI
- Amount recalled
- 5090
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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