Z-1247-2009

Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column...

Name: Z-1247-2009 Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column...
Creator: Del Medical Systems Group
Published: 2009-01-12
License: https://open.fda.gov/license/

Del Medical, Inc. / initiated 2009-01-12 / Terminated / root cause: design

FDA source

Del Medical Systems Group began a recall of Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension... on 2009-01-12. The reason FDA records is "There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1247-2009
Status: Terminated
Initiated: 2009-01-12
Posted: 2009-06-30
Terminated: 2010-06-17
Recalling firm: Del Medical, Inc.
Product: Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. The device is used for X-Ray tube positioning.
Product code: IYB Tube Mount, X-Ray, Diagnostic
Reason for recall: There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator.
Root cause tag: design
FDA root cause: Component design/selection
Action: Del Medical sent a "Field Correction Recall" letter with an acknowledgement form to the direct account dealers/assemblers on January 12, 2009 - February 4, 2009, informing them that required maintenance inspection of a retaining ring inside the column assembly may not be performed as required. If the retaining ring is not regularly inspected and replaced when worn or loose, there is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. The accounts were requested to locate the affected systems and immediately take them out of service until correction by installing a Cable Mount Retention Retrofit Kit to eliminate the potential for the cable to become detached. Affected accounts were instructed to complete the enclosed acknowledgement form and return it via fax (847-288-7911) or mail to Del Medical. If there are any questions, please contact Del Medical Technical Support at 800-800-6006 or 847-288-7000.
Quantity in commerce: 213 devices
Distribution: Worldwide Distribution -- US, Canada, Scotland and Pakistan.
Product codes and lots: All Model CTM and DCTM Ceiling Tube Mounts with either a 5 inch extension (Part 114-0304G2) or 10 inch extension (Part 114-0304G1). There are no serial numbers on the extensions.

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)