Known Identifiers & Locations
FEI Numbers
1720753
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0001-2007 |
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Reason: Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
|
2006-05-31 |
Terminated
|
View Details
|
| Z-0041-2007 |
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
Reason: Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
|
2006-09-13 |
Terminated
|
View Details
|
| Z-0042-2007 |
OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
Reason: X-ray system may lose or mix images and/or lose patient data.
|
2006-09-30 |
Terminated
|
View Details
|
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