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

FDA device recall Z-1247-2009 · posted 2009-06-30 · Terminated

Recall details

Recalling firm

Del Medical Systems Group

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

IYB

Quantity affected

213 devices

Distribution

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

Date initiated

2009-01-12

Date posted

2009-06-30

Date terminated

2010-06-17

Location

Franklin Park, IL