Z-0712-04

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

Name: Z-0712-04 DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension...
Creator: Del Medical Systems Group
Published: 2004-02-13
License: https://open.fda.gov/license/

Del Medical, Inc. / initiated 2004-02-13 / Terminated

FDA source

Del Medical Systems Group began a recall of DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of... on 2004-02-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0712-04
Status: Terminated
Initiated: 2004-02-13
Posted: 2004-07-20
Terminated: 2004-09-30
Recalling firm: Del Medical, Inc.
Product: 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.
Product code: IYB Tube Mount, X-Ray, Diagnostic
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.
FDA 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 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.
Quantity in commerce: 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
Product codes and lots: Model DCTM, serial numbers 00182-0303, 00337-0303, 00901-0503, 00948-0503, 02082-0703, 02083-0703, 02152-0703, 02153-0703, 02187-0703, 02188-0703, 02289-0703, 02460-0803, 02492-0803, 02493-0803, 02581-0803, 02730-0803, 02805-0803, 02809-0903, 02810-0903, 02811-0903, 02812-0903, 02866-0903, 02918-0903, 02989-0903, 02990-0903, 02991-0903, 03147-0903, 03148-0903, 03149-0903, 03457-1003, 03458-1003, 03544-1003, 03545-1003, 03624-1003, 03625-1003, 03756-1003, 03757-1003, 03888-1103, 03956-1103, 04085-1103, 04122-1103, 04154-1103, 04236-1103, 04248-1103, 04264-1103, 04371-1203, 04433-1203, 04439-1203, 04480-1203, 04529-1203, 04572-1203, 04634-1203, 04659-1203, 04709-1203, 00032-0104, 00085-0104, WG0031-0102-R

Product code IYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)