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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 Device Recall AXIOM ARISTOS FX see related information
Date Initiated by Firm April 14, 2015
Date Posted May 05, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1583-2015
Recall Event ID 71029
510(K)Number K013826  
Product Classification System, x-ray, stationary - Product Code KPR
Product AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
Code Information Model Number of device: 7414803, Serial #s:  1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083   
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
FDA Determined
Cause 2		 Device Design
Action The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.
Quantity in Commerce 43
Distribution Nationwide Distribution.
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 = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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