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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 Recall
Siemens Luminos dRF
see related information
Date Posted August 01, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-1848-2013
Recall Event ID 65491
Premarket Notification
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, Pennsylvania 19355
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
DESIGN: Process 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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