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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Mobilette Mira

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  Class 2 Device Recall Siemens Mobilette Mira see related information
Date Initiated by Firm October 10, 2012
Date Posting Updated December 06, 2012
Recall Status1 Terminated 3 on January 15, 2014
Recall Number Z-0480-2013
Recall Event ID 63495
510(K)Number K111912  
Product Classification System, x-ray, mobile - Product Code IZL
Product Siemens Mobilette Mira, intended use as Mobile x-ray system.
Code Information Model Number 10273100
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
Manufacturer Reason
for Recall
There is a risk of lost images during examination.
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

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 = IZL and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.