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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis Zee Multipurpose

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  Class 2 Device Recall Axiom Artis Zee Multipurpose see related information
Date Initiated by Firm October 26, 2009
Date Posted December 03, 2009
Recall Status1 Terminated 3 on January 26, 2010
Recall Number Z-0485-2010
Recall Event ID 53844
510(K)Number K073290  
Product Classification Angiographic x-ray system - Product Code IZI
Product Axiom Artis Zee Multi-purpose, Model number 10094139

angiographic x-ray systems
Code Information Serial numbers: 157136, 157139, 157146, 157156, 157164, 157165, 157168, 157169, 157184, 157213, and 157215.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith Adams
Manufacturer Reason
for Recall
c-arm may tilt
FDA Determined
Cause 2
Action The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
Quantity in Commerce 11 units
Distribution Nationwide
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 SOLUTIONS USA, INC.