Recall Z-0049-2007 ยท IZL System, X-Ray, Mobile
Del Medical Systems Group
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)
| Date | Oct 19, 2006 (initiated Oct 3, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 53 units |
| Distribution | Nationwide and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941363 | PHANTOM Dynarad Corp., Jul 20, 1994 |