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U.S. Department of Health and Human Services

Class 2 Device Recall LX125V Swivel Collimator, Model E600

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  Class 2 Device Recall LX125V Swivel Collimator, Model E600 see related information
Date Initiated by Firm August 10, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on March 18, 2010
Recall Number Z-1217-2007
Recall Event ID 38512
510(K)Number K874687  
Product Classification Radiographic Collimator - Product Code IZX
Product LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
Code Information Model E600, serial numbers VA163-1192 to VB985-0798, all swivel units manufactured between 11/14/1992 and 07/31/1998
Recalling Firm/
Manufacturer		 Summit Industries Inc.
2901 W Lawrence Ave
Chicago IL 60625-3621
For Additional Information Contact Mr. Stephen Lardner
773-353-4032
Manufacturer Reason
for Recall		 The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
FDA Determined
Cause 2		 Other
Action The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.
Quantity in Commerce 3034 for all units
Distribution Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.
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.
510(K) Database 510(K)s with Product Code = IZX and Original Applicant = SUMMIT INDUSTRIES, INC.
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