DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed

FDA device recall Z-0712-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Del Medical Systems Group

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

IYB

Quantity affected

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 Can

Date initiated

2004-02-13

Date posted

2004-07-20

Date terminated

2004-09-30

Location

Franklin Park, IL