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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 XP see related information
Date Initiated by Firm March 21, 2007
Date Posted April 19, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0751-2007
Recall Event ID 37698
Product Classification mobile X-ray system - Product Code IZL
Product Mobilett 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 Contact Roland 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
Action Siemens 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 Commerce 5 units
Distribution The products were shipped to medical facilities nationwide.
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.
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