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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Mobilett Mira

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 Class 2 Recall
Siemens Mobilett Mira
see related information
Date Posted September 11, 2012
Recall Status1 Terminated on September 25, 2012
Recall Number Z-2367-2012
Recall Event ID 62989
Premarket Notification
510(K) Number
K111912 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Code Information Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens has issued an Update Instruction XP018/12S in April 2012 to all affected consignees notifying them of the problem. The update instruction provides a correction of the wheel fixation. For questions call Siemens at 610-219-4834 or 610-448-4634.
Quantity in Commerce 9
Distribution US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
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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