Reported Jun 4, 2014 · Terminated
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging 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. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
- Lot codes and dates
- Model number 10433816
- Serial numbersUS:
125 of 125 codes
400290400425400439400441400443400447401176401591400763400787400789400790400791400792400794400797400063400860400868400872400873400877401041401187401441401540401590401602401662401696401638401641400174400882401612401501401507401561401378400297401423401429401550401491401494401562401572401584401621400803400821400570401010401020401235401252401564401611400998400999
- ROW0
132 of 132 codes
400652400733400737400746401437401443401478401495401188401191401650400546400945401506401371401325401393401403401543401571401580401581401613401620401623400302400348400347400553400558400726400995400996401120401123401209401260401288401338401344401442401452401551401555401556401522401560401577401579401588401589401603401604401606401643401699401630401676400125400200
- Amount recalled
- 257 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
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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