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Class 2 Device Recall Siemens Mobilette Mira |
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Date Initiated by Firm |
October 10, 2012 |
Date Posted |
December 06, 2012 |
Recall Status1 |
Terminated 3 on January 15, 2014 |
Recall Number |
Z-0480-2013 |
Recall Event ID |
63495 |
510(K)Number |
K111912
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Product Classification |
System, x-ray, mobile - Product Code IZL
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Product |
Siemens Mobilette Mira, intended use as Mobile x-ray system. |
Code Information |
Model Number 10273100 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact |
Anastasia Mason 610-219-4834
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Manufacturer Reason for Recall |
There is a risk of lost images during examination.
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FDA Determined Cause 2 |
Software design |
Action |
The firm initiated their recall/correction of this product on September 9, 2012 by sending a Field Safety Notification letter with Update Instruction XP054/12/S to all consignees. The letter described the steps to be taken to avoid the potential risk and included a response form to be returned to the recalling firm. |
Quantity in Commerce |
21 |
Distribution |
Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI. |
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 = IZL and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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