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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 Recall
Siemens Mobilette Mira
see related information
Date Posted December 06, 2012
Recall Status1 Terminated on January 15, 2014
Recall Number Z-0480-2013
Recall Event ID 63495
Premarket Notification
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/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall
There is a risk of lost images during examination.
FDA Determined
Cause 2
DESIGN: 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 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 = IZL and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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