LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
FDA Recall Z-1217-2007 · Posted 2007-08-29
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Recalling FirmSummit Industries Inc.
Recall StatusTerminated
Product CodeIZX
Date Initiated2007-08-10
Date Terminated2010-03-18
Product Quantity3034 for all units
Reason for Recall
The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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