FDA Medical Device Recalls (openFDA)
Dunlee: Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01
- Recall number
- Z-0839-05
- Recalling firm
- Dunlee
- Product
- Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); 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
- 4 units
- Distribution
- Nationwide and internationally to Taiwan, Germany and Mexico.
- Lot, serial or model codes
- Model DA 200 PRO and MX200 PRO, part number 884-01, serial (anode) numbers 17549, 18997, 21821, 23112
- 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