Reported Dec 14, 2016 · Terminated
SOMATOM Force, System x-ray, tomography, computed
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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SOMATOM Force, System x-ray, tomography, computed
- Lot codes and dates
- Model Number 10742326
- Serial Numbers
757087570975607756177555075526 755127556775536757117551475600755637551075454755407557175500 755277547575535754817548275710754607547675588754937545875528 754677560275487754647547875604755137553275555755247551575559 756107550175570756167557675605
- Amount recalled
- 48 units distributed in U.S.
Where it was sold
- Nationwide
Why it was recalled
Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
This product could cause temporary or reversible health problems — stop using it.
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