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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Luminos dRF

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  Class 2 Device Recall Siemens Luminos dRF see related information
Date Initiated by Firm May 07, 2013
Date Posting Updated August 01, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1848-2013
Recall Event ID 65491
510(K)Number K062623  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Siemens Luminos dRF Fluoroscopic X-Ray system

Fluoroscopic X-Ray system
Code Information Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact
Manufacturer Reason
for Recall
Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
FDA Determined
Cause 2
Software design
Action Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300.
Quantity in Commerce 4
Distribution US Distribution including the states of CA, IN, NJ and OK.
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.