Reported May 11, 2016 · Terminated
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms,…
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. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M
- Model number10433816
- Lot codes and dates
- Model number 10433816
- Serial numbers
402192400889402498402549400887402791401002402278402289402301401182402879400462400649402206402211402496402499401631402475400456402392402828402814400852401010402509400221400312402413402568402460402652402673402664400234402789401751401040400519402800400775400671401445402546402542402771402764401117401252402454402476402500402513402511401305401130
- Amount recalled
- 87
Where it was sold
- Nationwide
Why it was recalled
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
This product could cause temporary or reversible health problems — stop using it.
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