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U.S. Department of Health and Human Services

Class 2 Device Recall Luminos dRF Max

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  Class 2 Device Recall Luminos dRF Max see related information
Date Initiated by Firm January 08, 2020
Create Date February 20, 2020
Recall Status1 Terminated 3 on June 21, 2022
Recall Number Z-1337-2020
Recall Event ID 84815
510(K)Number K173639  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
Code Information Serial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Customer Service
800-888-7436
Manufacturer Reason
for Recall		 A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
FDA Determined
Cause 2		 Software design
Action On January 8, 2020, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to ensure that the image displayed after acquisition is a newly acquired image and belongs to the current patient. If the error occurs and a previously acquired image is duplicated, the user should delete the image and contact Siemens Customer Service at 1-800-888-7436 to report the incident. Siemens Healthineers will correct the error with a field software update which will be available beginning January 2020. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 46
Distribution US Nationwide distribution.
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, Inc
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