| Class 2 Device Recall PCS125 Swivel Collimator, Model F100 | |
Date Initiated by Firm | August 10, 2007 |
Date Posted | August 29, 2007 |
Recall Status1 |
Terminated 3 on March 18, 2010 |
Recall Number | Z-1218-2007 |
Recall Event ID |
38512 |
510(K)Number | K874687 |
Product Classification |
Radiographic Collimator - Product Code IZX
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Product | PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois |
Code Information |
Model F100, serial numbers WA153-1092 to WA153-0697, all swivel units manufactured between 10/01/1992 and 06/30/1997 |
Recalling Firm/ Manufacturer |
Summit Industries Inc. 2901 W Lawrence Ave Chicago IL 60625-3621
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For Additional Information Contact | Mr. Stephen Lardner 773-353-4032 |
Manufacturer Reason for Recall | The F100 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 |
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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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510(K) Database | 510(K)s with Product Code = IZX
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