Recall Z-1709-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
| Date | Sep 20, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE |
| Root cause | Equipment maintenance |
| Action | Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded. |
| Quantity | 660 units |
| Distribution | Nationwide Distribution including states of CA, FL, MS, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963952 | SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM Ge Dec Medical Systems, Dec 23, 1996 |