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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett XP

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 Class 2 Device Recall Mobilett XPsee related information
Date Initiated by FirmMarch 21, 2007
Date PostedApril 19, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall NumberZ-0751-2007
Recall Event ID 37698
Product Classification mobile X-ray system - Product Code IZL
ProductMobilett XP, mobile X-ray system, Model number 1818363
Code Information Serial numbers 1035, 1038, 1051, 1052, and 1056.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland Richter
610-448-4500
Manufacturer Reason
for Recall		Mounting bolts for tank fork assembly and collimator flange may become loose.
FDA Determined
Cause 2		Other
ActionSiemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.
Quantity in Commerce5 units
DistributionThe products were shipped to medical facilities nationwide.
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.
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