FDAFDA · Alimentos y medicamentos·N.º oficial Z-1437-2013
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
Publicado el 5 de junio de 2013 · Inicio del retiro: 22 de abril de 2013
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
Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Fisher & Paykel Healthcare, Ltd.
- Distribuidor
- Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
- Lote
- Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- New Zealand
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