Device product
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 visible on medical images such as CT, MRI, or X-ray.
Z-2236-2012
Product summary
- Event
- Event 62744
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 units
- Official record key
device-enforcement:Z-2236-2012
Official wording
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.
Code information: Model number A857680 with various serial numbers (refer to consignee list).
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.