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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 Recall
Siemens AXIOM Aristos FX Plus
see related information
Date Posted January 25, 2012
Recall Status1 Terminated on January 14, 2014
Recall Number Z-0860-2012
Recall Event ID 60789
Premarket Notification
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, Pennsylvania 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
PRODUCTION CONTROLS: 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 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 = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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