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Terminated

Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01

FDA Recall Z-0840-05 · Posted 2005-05-13

Recalling FirmDunlee
Recall StatusTerminated
Product CodeITY
Date Initiated2005-04-07
Date Terminated2005-10-20
Product Quantity37 units

Reason for Recall

The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Taiwan, Germany and Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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