FDAFDA · Alimentos y medicamentos·N.º oficial Z-0402-2013
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 17 de noviembre de 2011
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 firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Kerr Corporation
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
- Lote
- Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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