FDA Medical Device Recalls (openFDA)
Del Medical Systems Group: 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.
- Recall number
- Z-1247-2009
- Recalling firm
- Del Medical Systems Group
- 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.
- Status
- Terminated
- Initiated
- 2009-01-12
- Posted
- 2009-06-30
- Terminated
- 2010-06-17
- Reason
- 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
- 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
- 213 devices
- Distribution
- Worldwide Distribution -- US, Canada, Scotland and Pakistan.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYB
- Firm FEI
- 1418964
- Firm city
- Franklin Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28