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U.S. Department of Health and Human Services

Class 2 Device Recall Del CTM and DCTM Ceiling Tube Mount

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 Class 2 Device Recall Del CTM and DCTM Ceiling Tube Mountsee related information
Date Initiated by FirmJanuary 12, 2009
Date PostedJune 30, 2009
Recall Status1 Terminated 3 on June 17, 2010
Recall NumberZ-1247-2009
Recall Event ID 50841
Product Classification Del CTM and DCTM Ceiling Tube Mount - Product Code IYB
ProductCeiling 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.
Code Information 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.
FEI Number 1418964
Recalling Firm/
Manufacturer		 Del Medical Systems Group
11550 West King Street
Franklin Park IL 60131-1330
For Additional Information ContactMr. William J. Kostecki
847-288-7000
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionDel 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 Commerce213 devices
DistributionWorldwide Distribution -- US, Canada, Scotland and Pakistan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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