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U.S. Department of Health and Human Services

Class 2 Device Recall Dunlee DA 200 PRO & MX 200 PRO CT XRay Tube Housing Assembly

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 Class 2 Device Recall Dunlee DA 200 PRO & MX 200 PRO CT XRay Tube Housing Assemblysee related information
Date Initiated by FirmApril 07, 2005
Date PostedMay 13, 2005
Recall Status1 Terminated 3 on October 20, 2005
Recall NumberZ-0839-05
Recall Event ID 31457
Product Classification Assembly, Tube Housing, X-Ray, Diagnostic - Product Code ITY
ProductDunlee 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
Code Information Model DA 200 PRO and MX200 PRO, part number 884-01, serial (anode) numbers 17549, 18997, 21821, 23112
FEI Number 1483239
Recalling Firm/
Manufacturer		 Dunlee
555 Commerce St
Aurora IL 60504-8110
For Additional Information ContactMr. John M. Macko
800-238-3780
Manufacturer Reason
for Recall		The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
FDA Determined
Cause 2		Other
ActionDunlee 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 Commerce4 units
DistributionNationwide and internationally to Taiwan, Germany and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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