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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 Device Recall Siemens Mobilett Mirasee related information
Date Initiated by FirmApril 30, 2012
Date PostedSeptember 11, 2012
Recall Status1 Terminated 3 on September 25, 2012
Recall NumberZ-2367-2012
Recall Event ID 62989
510(K)NumberK111912 
Product Classification System, x-ray, mobile - Product Code IZL
ProductSiemens 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 PA 19355
For Additional Information Contact
610-219-6300
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		Device Design
ActionSiemens 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 Commerce9
DistributionUS Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZL
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