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U.S. Department of Health and Human Services

Class 2 Device Recall Del Medical DCTM Ceiling Tube Mount

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  Class 2 Device Recall Del Medical DCTM Ceiling Tube Mount see related information
Date Initiated by Firm February 13, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 30, 2004
Recall Number Z-0712-04
Recall Event ID 28372
Product Classification Tube Mount, X-Ray, Diagnostic - Product Code IYB
Product DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.
Code Information Model DCTM, serial numbers 00182-0303, 00337-0303, 00901-0503, 00948-0503, 02082-0703, 02083-0703, 02152-0703, 02153-0703, 02187-0703, 02188-0703, 02289-0703, 02460-0803, 02492-0803, 02493-0803, 02581-0803, 02730-0803, 02805-0803, 02809-0903, 02810-0903, 02811-0903, 02812-0903, 02866-0903, 02918-0903, 02989-0903, 02990-0903, 02991-0903, 03147-0903, 03148-0903, 03149-0903, 03457-1003, 03458-1003, 03544-1003, 03545-1003, 03624-1003, 03625-1003, 03756-1003, 03757-1003, 03888-1103, 03956-1103, 04085-1103, 04122-1103, 04154-1103, 04236-1103, 04248-1103, 04264-1103, 04371-1203, 04433-1203, 04439-1203, 04480-1203, 04529-1203, 04572-1203, 04634-1203, 04659-1203, 04709-1203, 00032-0104, 00085-0104, WG0031-0102-R
Recalling Firm/
Manufacturer		 Del Medical Systems Group
11550 West King Street
Franklin Park IL 60131-1330
For Additional Information Contact Mr. William J. Engel
800-800-6006
Manufacturer Reason
for Recall		 There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units.
FDA Determined
Cause 2		 Other
Action Del Medical sent a Field Correction Recall letter dated 2/13/04 to all dealers/assemblers receiving DCTM''s during the affected time frame, alerting them to potential defective worm gear. The accounts were asked to locate the systems listed in the attachment to the letter, and alert the end users to take the units out of service until they can be inspected. Follow-up letters were sent via registerd mail on 2/19/04, reiterating the 2/13/04 letter and providing the accounts with instructions for inspection of the balancers. If the worm gear fails the test, the dealers were instructed to contact Del Medical for replacement of the balancer and assure that the unit is not placed back in service until the balancer has been replaced.
Quantity in Commerce 57 units
Distribution Nevada, Ohio, Tennessee, Nebraska, Arizona, Maryland, Wisconsin, Florida, Texas, Kansas, Oklahoma, Illinois, Colorado, California, Minnesota, Michigan, Alabama, Rhode Island and internationally to Canada, Panama and Pakistan
Total Product Life Cycle TPLC 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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