Recall Z-0839-05 ยท ITY Assembly, Tube Housing, X-Ray, Diagnostic
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
| Date | May 13, 2005 (initiated Apr 7, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.