FDA Recall Terminated

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.

Recall: Z-0712-04 · Initiated February 13, 2004

Recall

Recall Number
Z-0712-04
Event Number
28372
Firm
Del Medical Systems Group
FEI Number
1418964
Product Code
IYB
Status
Terminated
Root Cause
Other
Initiated
February 13, 2004
Posted
July 20, 2004
Terminated
September 30, 2004
Address
11550 West King Street, Franklin Park, IL, 60131-1330

Description

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.

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.

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 contact Del Medical for replacement of the balancer and assure that the unit is not placed back in service until the balancer has been replaced.

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

Quantity

57 units