Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
Publicado el 7 de agosto de 2019 · Inicio del retiro: 7 de junio de 2019
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
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Burlington Medical, LLC
- Distribuidor
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- Lote
- Serial Numbers: 419558 419557 414132
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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