Recall Z-0728-04 ยท KPR System, X-Ray, Stationary
Eastman Kodak Co
Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system 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 | Jul 20, 2004 (initiated Feb 20, 2004) |
| Status | Terminated |
| Reason | Defective component in overhead tube support balancer may cause the suspended load to fall. |
| Root cause | Other |
| Action | 2/20/2004: Field representatives notified the customer in China that the unit should not be used until the OTS Balancer component can be repaired/replaced. |
| Quantity | 3 units |
| Distribution | Amsterdam, China and Kuwait. |
| 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 |