Recall Z-2236-2012 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visibl
| Date | Aug 22, 2012 (initiated Oct 11, 2006) |
| Status | Terminated |
| Reason | GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use. |
| Root cause | Component design/selection |
| Action | GE Healthcare sent an "URGENT SAFETY ADVISORY NOTICE" dated October 11, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter stated that GEHC OEC Field Service Engineers would be contacting their facility to place a caution label on the articulating monitor arm of the cart and to provide a revised operators manual that will contain additional information on the safe usage of the cart. Until a GEHC Engineer had taken the actions described, they advised their consignees to exercise caution when fully extending the art |
| Quantity | 99 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003510 | INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 Visualization Technology, Inc., Feb 12, 2001 |