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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Luminos dRF system or Luminos dRF Max

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  Class 2 Device Recall AXIOM Luminos dRF system or Luminos dRF Max see related information
Date Initiated by Firm August 12, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-2649-2014
Recall Event ID 69067
510(K)Number K062623  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max

The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Code Information model # 10094200, see distribution list for individual device serial numbers
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		 It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d
FDA Determined
Cause 2		 Equipment maintenance
Action Siemens sent a Customer Safety Advisory Notice XP045/14/S, dated August 12, 2014, to direct accounts, which identified the product, problem, and action to be taken to avoid potential risk to patients and users. Customers were instructed to avoid extensive exposure of fluids to the tableside control panel. When cleaning the system, customers were instructed not to appoly excessive fluids, only use damp towels, in accordance with the product manual. Customers were asked to forward the safety notice to any of their customers and to inform Siemens of the identify of the device's new owner where possible. For questions regarding this recall call 610-219-6300.
Quantity in Commerce 33
Distribution Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.
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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