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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis BA or BC Biplane System

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  Class 2 Device Recall Axiom Artis BA or BC Biplane System see related information
Date Initiated by Firm August 10, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 on January 25, 2005
Recall Number Z-1450-04
Recall Event ID 29919
510(K)Number K010721  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656
Code Information Serial numbers: 28000, and 28002-28118
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		 Opacification Function of device may incorrectly merge images
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 34 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
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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