Z-0838-05

Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing...

Name: Z-0838-05 Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing...
Creator: Dunlee
Published: 2005-04-07
License: https://open.fda.gov/license/

Chronos Imaging, LLC / initiated 2005-04-07 / Terminated

FDA source

Dunlee began a recall of Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora... on 2005-04-07. The reason FDA records is "The x-ray tube housing assembly may have been mounted with the incorrect sized bolts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0838-05
Status: Terminated
Initiated: 2005-04-07
Posted: 2005-05-13
Terminated: 2005-10-20
Recalling firm: Chronos Imaging, LLC
Product: Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01
Product code: ITY Assembly, Tube Housing, X-Ray, Diagnostic
Reason for recall: The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
FDA root cause: Other
Action: Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.
Quantity in commerce: 69 units
Distribution: Nationwide and internationally to Taiwan, Germany and Mexico.
Product codes and lots: Model DA 200 and MX200, part number 875-01, serial (anode) numbers 13426, 13428, 13437, 13449, 15714, 16539, 16941, 16942, 16951, 16962, 16963, 17536, 17539, 17541, 17543, 17547, 18727, 18728, 18729, 18731, 18732, 18733, 18736, 18743, 18745, 18747, 18749, 18753, 18755, 18999, 20206, 20208, 20211, 20216, 20219, 20220, 20222, 20225, 21800, 21803, 21806, 21809, 21810, 21816, 21818, 21819, 21820, 21823, 21824, 21825, 21827, 21829, 21843, 21849, 21853, 23113, 23122, 23132, 23140, 23143, 23144, 23516, 23518, 23522, 23524, 23532, 23534, 23554, 23888

Product code ITY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)