Atlas FDA

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

FDA device recall Z-0838-05 · posted 2005-05-13 · Terminated

Recall details

Recalling firm
Dunlee
Reason for recall
The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
ITY
Quantity affected
69 units
Distribution
Nationwide and internationally to Taiwan, Germany and Mexico.
Date initiated
2005-04-07
Date posted
2005-05-13
Date terminated
2005-10-20
Location
Aurora, IL

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