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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Axiom Aristos FX and FX Plus System

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  Class 2 Device Recall Siemens Axiom Aristos FX and FX Plus System see related information
Date Initiated by Firm February 17, 2011
Date Posted April 12, 2011
Recall Status1 Terminated 3 on July 16, 2013
Recall Number Z-1959-2011
Recall Event ID 58110
510(K)Number K013826  K061054  
Product Classification System, x-ray, stationary - Product Code KPR
Product Axiom Aristos FX and FX Plus System

Intended use: Stationary x-ray system
Code Information Model numbers 10093864 and 7414803 -- Serial numbers up to and including 1216.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith A. Adams
610-448-3237
Manufacturer Reason
for Recall		 During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect
FDA Determined
Cause 2		 Other
Action The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.
Quantity in Commerce 101
Distribution Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.
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 SOLUTIONS USA INC.
510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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