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 visible on medical images such as CT, MRI, or X-ray. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Model number A857680 with various serial numbers (refer to consignee list).
Products Sold
Model number A857680 with various serial numbers (refer to consignee list).
GE OEC Medical Systems, Inc is recalling OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomi due to 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 extend. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 articulating monitor arm on the device to avoid potentially tipping over the cart. Contact the firm at 800-874-7378 for questions regarding this notice.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026