FDAFDA · Alimentos y medicamentos·N.º oficial Z-2236-2012
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.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 11 de octubre de 2006
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE OEC Medical Systems, Inc
- Distribuidor
- Nationwide Distribution.
- Lote
- Model number A857680 with various serial numbers (refer to consignee list).
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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