Date Initiated by Firm |
May 07, 2013 |
Date Posted |
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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