Date Initiated by Firm |
August 25, 2008 |
Date Posted |
October 20, 2008 |
Recall Status1 |
Terminated 3 on October 20, 2008 |
Recall Number |
Z-0163-2009 |
Recall Event ID |
49567 |
510(K)Number |
K013826
|
Product Classification |
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTE - Product Code KPR
|
Product |
Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803. |
Code Information |
Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135. |
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 |
Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
|
FDA Determined Cause 2 |
Equipment maintenance |
Action |
Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems. |
Quantity in Commerce |
7 units |
Distribution |
Nationwide distribution including states of CA, IN, KY, UT, VA and WI. |
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 = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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