Recall Z-0274-06 ยท KPR System, X-Ray, Stationary
Eastman Kodak Co
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.
| Date | Dec 8, 2005 (initiated Oct 20, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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). |
| Quantity | 3 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001341 | DR5000 DEDICATED CHEST X-RAY SYSTEM Analogic Corp., Jun 2, 2000 |