Recall Z-0816-05 ยท IYB Tube Mount, X-Ray, Diagnostic
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
| Date | May 11, 2005 (initiated Mar 10, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 31 stands |
| Distribution | Nationwide, Mexico and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.