KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
FDA Recall Z-0274-06 · Posted 2005-12-08
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Recalling FirmEastman Kodak Co
Recall StatusTerminated
Product CodeKPR
Date Initiated2005-10-20
Date Terminated2005-12-30
Product Quantity3
Reason for Recall
Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
Firm Action
Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).
Root Cause
Other
Distribution Pattern
DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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