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Class 2 Device Recall Siemens SOMATOM Force |
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Date Initiated by Firm |
October 20, 2016 |
Date Posted |
December 02, 2016 |
Recall Status1 |
Terminated 3 on May 30, 2017 |
Recall Number |
Z-0692-2017 |
Recall Event ID |
75594 |
510(K)Number |
K133589
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
SOMATOM Force, System x-ray, tomography, computed |
Code Information |
Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact |
Marlynne Galloway 610-448-6471
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Manufacturer 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.
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FDA Determined Cause 2 |
Under Investigation by 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. |
Quantity in Commerce |
48 units distributed in U.S. |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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