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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
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/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Michael Van Ryn
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.