Date Initiated by Firm |
September 03, 2008 |
Date Posted |
January 05, 2009 |
Recall Status1 |
Terminated 3 on September 23, 2009 |
Recall Number |
Z-0321-2009 |
Recall Event ID |
50077 |
510(K)Number |
K040665
|
Product Classification |
Computed tomography x-ray system - Product Code JAK
|
Product |
Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. |
Code Information |
Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Michael Van Ryn 610-448-4500
|
Manufacturer Reason for Recall |
software error - does not allow protocol to properly synchronize with ECG triggers
|
FDA Determined Cause 2 |
Software design |
Action |
The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500. |
Quantity in Commerce |
9 units |
Distribution |
Nationwide |
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.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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