Recall Z-1247-2009 ยท IYB Tube Mount, X-Ray, Diagnostic
Del Medical Systems Group
Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. The device is used for X-Ray tube positioning.
| Date | Jun 30, 2009 (initiated Jan 12, 2009) |
| Status | Terminated |
| Reason | There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. |
| Root cause | Component design/selection |
| Action | Del Medical sent a "Field Correction Recall" letter with an acknowledgement form to the direct account dealers/assemblers on January 12, 2009 - February 4, 2009, informing them that required maintenance inspection of a retaining ring inside the column assembly may not be performed as required. If the retaining ring is not regularly inspected and replaced when worn or loose, there is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. The accounts were requested to locate the affected systems and im |
| Quantity | 213 devices |
| Distribution | Worldwide Distribution -- US, Canada, Scotland and Pakistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.