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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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