FDA Medical Device Recalls (openFDA)
Dunlee: 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
- Recall number
- Z-0838-05
- Recalling firm
- Dunlee
- 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
- Status
- Terminated
- Initiated
- 2005-04-07
- Posted
- 2005-05-13
- Terminated
- 2005-10-20
- Reason
- The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
- 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
- 69 units
- Distribution
- Nationwide and internationally to Taiwan, Germany and Mexico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITY
- Firm FEI
- 1483239
- Firm city
- Aurora
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28