FDA-Device2016-12-14Class II

SOMATOM Force, System x-ray, tomography, computed

Siemens Medical Solutions USA, Inc
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.

Sold states
Nationwide Distribution.
Affected count
48 units distributed in U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Force, System x-ray, tomography, computed

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2017

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