Reported Sep 22, 2021 · Terminated
ACUSON Juniper 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
- Lot codes and dates
- Model Number11335791
- UDI(01)04056869152059 (21)123456 (240)11335791 (422)410 Firmware version 3.8 for rev. 7 U.S
- Serial Number555606; O.U.S
- Serial Numbers
550975552770553629553951555060555601555602555604555605555610555611555612555613555626O.U.S
- Inactive Serial Numbers
555603555607
- Amount recalled
- 15 systems
Where it was sold
- Nationwide
- PR
Why it was recalled
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
This product could cause temporary or reversible health problems — stop using it.
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