Reported Jun 4, 2014 · Terminated
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging…
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) and using Stress Echo Feature. Ultrasound imaging system.
- Lot codes and dates
- ACUSON SC2000 model number10433816
- Stress Echo Feature model number1044966
- Serial numbers - USA
97 of 97 codes
400290400425400439400441400443400447401176400787400789400790400791400792400794400797400063400877401187401441401590401602401638400174401612401501401507401561400297401423401429401550401491401494401562401572401584401621400570401010401020401235401252401564401611400998400999400979401625401631400234400312400972401645400108400177400203400313400650400663400664400176
- ROW
80 of 80 codes
400652400733400737400746401437401443401478401495401650400546401506401371401325401581401620401623400302400348400347400553400558400726400995400996401120401123401209401260401338401344401442401452401551401555401556401522401560401577401579401588401589401603401604401606401643401699400125400200401434401626401615400155400180400307400704401428401541401624401004401546
- Amount recalled
- 177 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
- Nationwide
Why it was recalled
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.
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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