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Class 2 Device Recall Axiom Artis MP XRay System |
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Date Initiated by Firm |
April 01, 2005 |
Date Posted |
May 11, 2005 |
Recall Status1 |
Terminated 3 on August 18, 2005 |
Recall Number |
Z-0818-05 |
Recall Event ID |
31647 |
510(K)Number |
K010721
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Product Classification |
System, X-Ray, Angiographic - Product Code IZI
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Product |
Axiom Artis MP X-Ray System |
Code Information |
Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact |
Roland Richter 610-448-1777
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Manufacturer Reason for Recall |
potential problem with the fluoroscopy switch on the power grip
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button. |
Quantity in Commerce |
21 units |
Distribution |
The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, 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.
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510(K) Database |
510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL CORP.
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