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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm December 05, 2013
Date Posted March 27, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-1202-2014
Recall Event ID 67016
510(K)Number K123529  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Siemens Artis Q and Artis Q biplane systems


Product Usage: Interventional Fluoroscopic X-ray
Code Information model numbers 10848280, 10848281, 10848282, and 10848283.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
FDA Determined
Cause 2		 Device Design
Action Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
Quantity in Commerce 19
Distribution USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
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 = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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