Del Medical Systems Group Recalls
Showing 1-4 of 4 recalls
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.
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.
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.
DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)
The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.
Del Medical sent Field Correction Recall letters dated 10/3/06 to the direct accounts, informing them of the potential for the shoulder bolt in the yoke assembly to come loose. If the shoulder bolt comes loose, the tube head could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.
Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
Del Medical sent Field Correction Recall letters dated 3/10/05 to the direct accounts, informing them of the potential for a defective weld supporting the braket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.
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.
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.
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.