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.
This recall has been terminated (originally issued June 30, 2009).
- Company
- Del Medical Systems Group
- Recall Initiated
- January 12, 2009
- Posted
- June 30, 2009
- Terminated
- June 17, 2010
- Recall Number
- Z-1247-2009
- Quantity
- 213 devices
- Firm Location
- Franklin Park, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- US, Canada, Scotland and Pakistan.
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.