DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-
FDA device recall Z-0049-2007 · posted 2006-10-19 · Terminated
Recall details
- Recalling firm
- Del Medical Systems Group
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 53 units
- Distribution
- Nationwide and Thailand
- Date initiated
- 2006-10-03
- Date posted
- 2006-10-19
- Date terminated
- 2008-01-24
- Location
- Franklin Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHANTOM (K941363) | Dynarad Corp. | 1994-07-20 |