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U.S. Department of Health and Human Services

Class 2 Device Recall SIEMENS Axiom Luminos dRF Max

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 Class 2 Device Recall SIEMENS Axiom Luminos dRF Maxsee related information
Date Initiated by FirmApril 13, 2015
Date PostedMay 23, 2015
Recall Status1 Terminated 3 on March 20, 2017
Recall NumberZ-1668-2015
Recall Event ID 71115
510(K)NumberK062623 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSIEMENS Axiom Luminos dRF Max, 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 Number of device  10762471with serial numbers: 5043 5085 5069 5086 5037 5072 5049 5039 5120 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
FDA Determined
Cause 2		Software design
ActionA safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.
Quantity in Commerce133 total
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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