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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens AXIOM Aristos FX Plus

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  Class 2 Device Recall Siemens AXIOM Aristos FX Plus see related information
Date Initiated by Firm December 12, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0860-2012
Recall Event ID 60789
510(K)Number K061054  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Siemens AXIOM Aristos FX Plus solid state x-ray imager.

Image-intensified fluoroscopic x-ray system.
Code Information Serial number 1273
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.
FDA Determined
Cause 2		 Process control
Action Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.
Quantity in Commerce 1
Distribution Product distributed in one hospital in California.
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 = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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