SOMATOM Force, System x-ray, tomography, computed
FDA Recall Z-0692-2017 · Posted 2016-12-02
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Recalling FirmSiemens Medical Solutions USA, Inc
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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