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Class 2 Device Recall Axiom Iconos R200 |
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Date Initiated by Firm |
January 29, 2010 |
Date Posted |
March 27, 2010 |
Recall Status1 |
Terminated 3 on August 11, 2010 |
Recall Number |
Z-1213-2010 |
Recall Event ID |
54616 |
510(K)Number |
K992660
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Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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Product |
Axiom Iconos R200 X-Ray |
Code Information |
Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact |
Technical Support 888-826-9702
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Manufacturer Reason for Recall |
table can tilt/move when it is not intended
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FDA Determined Cause 2 |
Software design |
Action |
The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device. |
Quantity in Commerce |
169 units |
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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