FDAOctober 20, 2016device

SOMATOM Force, System x-ray, tomography, computed

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

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SOMATOM Force, System x-ray, tomography, computed — Recall Details · AllClear