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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/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact
610-219-6300
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.
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