Recall Z-0712-04 ยท IYB Tube Mount, X-Ray, Diagnostic
Del Medical Systems Group
DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.
| Date | Jul 20, 2004 (initiated Feb 13, 2004) |
| Status | Terminated |
| Reason | There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units. |
| Root cause | Other |
| Action | Del Medical sent a Field Correction Recall letter dated 2/13/04 to all dealers/assemblers receiving DCTM''s during the affected time frame, alerting them to potential defective worm gear. The accounts were asked to locate the systems listed in the attachment to the letter, and alert the end users to take the units out of service until they can be inspected. Follow-up letters were sent via registerd mail on 2/19/04, reiterating the 2/13/04 letter and providing the accounts with instructions for inspection of the balancers. If the worm gear fails the test, the dealers were instructed to conta |
| Quantity | 57 units |
| Distribution | Nevada, Ohio, Tennessee, Nebraska, Arizona, Maryland, Wisconsin, Florida, Texas, Kansas, Oklahoma, Illinois, Colorado, California, Minnesota, Michigan, Alabama, Rhode Island and internationally to Canada, Panama and Pakistan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.