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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Dunlee
Lot Codes / Batch Numbers
Model DA 200 PRO and MX200 PRO, part number 884-01, serial (anode) numbers 17549, 18997, 21821, 23112
Products Sold
Model DA 200 PRO and MX200 PRO, part number 884-01, serial (anode) numbers 17549, 18997, 21821, 23112
Dunlee is recalling Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube due to The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026