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Class 2 Device Recall Axiom Artis BA or BC Biplane System |
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Date Initiated by Firm |
August 10, 2004 |
Date Posted |
September 14, 2004 |
Recall Status1 |
Terminated 3 on January 25, 2005 |
Recall Number |
Z-1449-04 |
Recall Event ID |
29919 |
510(K)Number |
K010721
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Product Classification |
System, X-Ray, Angiographic - Product Code IZI
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Product |
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 |
Code Information |
Serial numbers: 14002-14004, 14006-14012, 14014, 14018, 14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049, 14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071, 14074-14075, 14080-14081, 14084-14088, and 14092 |
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 |
Opacification Function of device may incorrectly merge images
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem. |
Quantity in Commerce |
37 units |
Distribution |
The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA. |
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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