Enforcement Report - Week of August 29, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2236-2012 |
| Classification | Class II |
| Code Info | Model number A857680 with various serial numbers (refer to consignee list). |
| Product Distributed Qty | 99 units |
| Reason For Recall | 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. |
Event Detail
| Event Id | 62744 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | GE OEC Medical Systems, Inc |
| City | Salt Lake City |
| State | UT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2006-10-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
-
