Date Initiated by Firm |
January 31, 2007 |
Date Posted |
March 08, 2007 |
Recall Status1 |
Terminated 3 on May 05, 2009 |
Recall Number |
Z-0579-2007 |
Recall Event ID |
37389 |
510(K)Number |
K010721
|
Product Classification |
Angiographic x-ray system - Product Code IZI
|
Product |
AXIOM Artis MP, Angiographic x-ray system, model number 7555365 |
Code Information |
Model number 7555365 - serial numbers 57004, 57008, 57009, 57012, 57045, 57016, 57024 and 57041 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Roland Richter 610-448-1777
|
Manufacturer Reason for Recall |
C-arm gantry could rapidly descend without command during use
|
FDA Determined Cause 2 |
Other |
Action |
In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary. |
Quantity in Commerce |
8 units |
Distribution |
The products were shipped to medical facilities 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 = IZI and Original Applicant = SIEMENS MEDICAL CORP.
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