Z-1216-2007

LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago...

Name: Z-1216-2007 LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago...
Creator: Summit Industries Inc.
Published: 2007-08-10
License: https://open.fda.gov/license/

Summit Industries, LLC / initiated 2007-08-10 / Terminated

FDA source

Summit Industries Inc. began a recall of LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois on 2007-08-10. The reason FDA records is "The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1216-2007
Status: Terminated
Initiated: 2007-08-10
Posted: 2007-08-29
Terminated: 2010-03-18
Recalling firm: Summit Industries, LLC
Product: LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
Product code: IZX Collimator, Manual, Radiographic
Reason for recall: The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
FDA root cause: 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.
Product codes and lots: Model D800, serial numbers NA578-1092 to NE785-0201, all swivel units manufactured between 11/14/1992 and 02/13/2001

Product code IZX

K874687Class IIColli-Matetm Model No. B800Summit Industries, Inc. / cleared 1987-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)