Reported Oct 30, 2013 · Terminated
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc.…
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 volume imaging ultrasound systems at software version 3.0
- Mfg nameSiemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes
- Lot codes and dates
- Model# 10433816 Software Version 3.0 Serial#'s:
401239401189401214400416400599400600401254401260401259401161400836401111401290400641401116401236401245401241401255401361400141401108401109401213400675400882
- Model# 10433816 Software Version 3.0 Serial#'s:
- Amount recalled
- 26 units
Where it was sold
Why it was recalled
Software issue results in inaccurate 3D image may result in ablation in wrong location.
This product could cause temporary or reversible health problems — stop using it.
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