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Class 2 Device Recall Mobilett XP |
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Date Initiated by Firm |
March 21, 2007 |
Date Posted |
April 19, 2007 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0750-2007 |
Recall Event ID |
37698 |
Product Classification |
mobile X-ray system - Product Code IZL
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Product |
Mobilett XP, mobile X-ray system, Model number 1818447 |
Code Information |
Serial numbers 2033, 1034, 1010, 1020, 1041, 1053, 2044, 2045, 1008, 1043, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1040, 2007, 1052, 2001, 1017, 2002, 2040, 2021, 2022, 1011, 1016, 1018, 1021, 1039, 1054, 2005, and 2017. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact |
Roland Richter 610-448-4500
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Manufacturer Reason for Recall |
Mounting bolts for tank fork assembly and collimator flange may become loose.
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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 |
36 units |
Distribution |
The products were shipped to medical facilities nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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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