FDA Recall Terminated

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: Z-1247-2009 · Initiated January 12, 2009

Recall

Recall Number: Z-1247-2009
Event Number: 50841
Firm: Del Medical Systems Group
FEI Number: 1418964
Product Code: IYB
Status: Terminated
Root Cause: Component design/selection
Initiated: January 12, 2009
Posted: June 30, 2009
Terminated: June 17, 2010
Address: 11550 West King Street, Franklin Park, IL, 60131-1330

Description

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.

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.

Distribution

Worldwide Distribution -- US, Canada, Scotland and Pakistan.

Quantity

213 devices