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Terminated

SOMATOM Force, System x-ray, tomography, computed

FDA Recall Z-0692-2017 · Posted 2016-12-02

Recall StatusTerminated
Product CodeJAK
Date Initiated2016-10-20
Date Terminated2017-05-30
Product Quantity48 units distributed in U.S.

Reason for Recall

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.

Firm Action

Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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