Del Medical Systems Group Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.