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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Aristos FX

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 Class 2 Recall
Axiom Aristos FX
see related information
Date Posted October 20, 2008
Recall Status1 Terminated on October 20, 2008
Recall Number Z-0163-2009
Recall Event ID 49567
Premarket Notification
510(K) Number
K013826 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
Code Information Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall
Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
Quantity in Commerce 7 units
Distribution Nationwide distribution including states of CA, IN, KY, UT, VA and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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