Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 6

FDA device recall Z-0816-05 · posted 2005-05-11 · Terminated

Recall details

Recalling firm

Del Medical Systems Group

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IYB

Quantity affected

31 stands

Distribution

Nationwide, Mexico and Thailand.

Date initiated

2005-03-10

Date posted

2005-05-11

Date terminated

2005-11-14

Location

Franklin Park, IL